News from the FDA/CDC

The recent approval of the first oral fecal-derived microbiota therapy to prevent the recurrence of Clostridioides difficile (C. diff) infection in patients was welcome news for physicians who’ve struggled under the weight of having too few treatment options for the prevention of C. diff recurrence.

The product, developed by Massachusetts-based Seres Therepeutics and marketed as Vowst, was approved by the U.S. Food and Drug Administration on April 26. It is approved for use in adults who have already been treated with antibiotics for a recurrent infection with C. diff bacteria.

This is the first oral treatment for the prevention of C. diff recurrence and is designed to be delivered in four capsules taken daily for 3 days.

Gastroenterologist Phillip I. Tarr, MD, division chief of gastroenterology at Washington University, St. Louis, and chair of the American Gastroenterological Association Center for Gut Microbiome Research and Education, said that prevention of recurrent C. diff infection “remains challenging,” and that Vowst “provides the first FDA-approved, orally administered microbiome therapeutic with which to achieve this goal. This advance also makes us optimistic we might soon be able to prevent other disorders by managing gut microbial communities.”

Vowst is the second therapy derived from human stool to be approved for the indication in less than 6 months. In December, the FDA approved Rebyota (Ferring), a rectally delivered treatment that also uses microbes from donor feces. Both products were given priority review, orphan drug, and breakthrough therapy designations by the agency.

C. diff infection can be aggravated by an alteration of normal gut flora associated with antibiotics treatment, leading to cycles of repeated infections. Infection can produce diarrhea, abdominal pain, fever, and severe morbidity. In the United States, an estimated 15,000 to 30,000 deaths per year are linked to C. diff. Risk factors for recurrent infection include being 65 or older, hospitalization, being in a nursing home, a weakened immune system, and previous infection with C. diff.

Therapies transplanting fecal microbiota from donors have been used since the 1950s as treatments for recurrent C. diff infection, and in the past decade, as stool banks recruiting screened donors have made fecal microbiota transplants, or FMT, standard of care. However, only in recent years have fecal-derived therapies become subject to standardized safety and efficacy testing.

Both the current FDA-approved products, Rebyota and Vowst, were shown in randomized controlled trials to reduce recurrence of C. diff infection, compared with placebo. In a phase 3 clinical trial of Rebyota (n = 262) in antibiotic-treated patients, one rectally administered dose reduced recurrence of C. diff infection by 70.6% at 8 weeks, compared with 57.5% for placebo. A phase 3 study of Vowst (n = 281) showed recurrence in treated subjects to be 12.4% at 8 weeks, compared with nearly 40% of those receiving placebo (relative risk, 0.32; 95% confidence interval, 0.18-0.58; P less than .001).

Despite screening protocols that have become increasingly homogenized and rigorous, FMT is associated with the risk of introducing pathogens. Vowst is manufactured with purified bacterial spores derived from donor feces, not whole stool. Nonetheless, FDA noted in its statement that Vowst could still potentially introduce infectious agents or allergens.
 

Antibiotics are still first-line treatment

In an interview, Jessica Allegretti, MD, MPH, AGAF, medical director of the Crohn’s and Colitis Center at Brigham & Women’s Hospital, Boston, said that having two FDA-approved therapies with different means of administration “is great for the field and great for patients. These are both meant to be used after a course of antibiotics, so antibiotics are still the mainstay of treatment for C. diff and recurrent C. diff, but we now have more options to prevent recurrence.”

The convenience of an oral therapy that can be taken at home is “very attractive,” Dr. Allegretti added, noting that there will also be patients “who either don’t want to or can’t take capsules, for whom a rectal administration [in a health care setting] may be preferred.”

Dr. Allegretti, who has used FMT to treat recurrent C. difficile for more than a decade, said that she expected traditional FMT using screened donor stool to remain available even as the new products are adopted by clinicians. FMT centers like OpenBiome “will continue to provide access for patients who either don’t have the ability to get the FDA-approved products because of insurance coverage, or for financial reasons, or maybe neither of the new products is appropriate for them,” she said. “I do think there will always be a need for the traditional option. The more options that we have available the better.”

TD Cowen analyst Joseph Thome told Reuters that the drug could be priced close to $20,000 per course, expecting peak sales of $750 million in the U.S. in 2033.

Dr. Allegretti disclosed consulting work for Seres Therapeutics, Ferring, and other manufacturers. She is a member of OpenBiome’s clinical advisory board.

The recent approval of the first oral fecal-derived microbiota therapy to prevent the recurrence of Clostridioides difficile (C. diff) infection in patients was welcome news for physicians who’ve struggled under the weight of having too few treatment options for the prevention of C. diff recurrence.

The product, developed by Massachusetts-based Seres Therepeutics and marketed as Vowst, was approved by the U.S. Food and Drug Administration on April 26. It is approved for use in adults who have already been treated with antibiotics for a recurrent infection with C. diff bacteria.

This is the first oral treatment for the prevention of C. diff recurrence and is designed to be delivered in four capsules taken daily for 3 days.

Gastroenterologist Phillip I. Tarr, MD, division chief of gastroenterology at Washington University, St. Louis, and chair of the American Gastroenterological Association Center for Gut Microbiome Research and Education, said that prevention of recurrent C. diff infection “remains challenging,” and that Vowst “provides the first FDA-approved, orally administered microbiome therapeutic with which to achieve this goal. This advance also makes us optimistic we might soon be able to prevent other disorders by managing gut microbial communities.”

Vowst is the second therapy derived from human stool to be approved for the indication in less than 6 months. In December, the FDA approved Rebyota (Ferring), a rectally delivered treatment that also uses microbes from donor feces. Both products were given priority review, orphan drug, and breakthrough therapy designations by the agency.

C. diff infection can be aggravated by an alteration of normal gut flora associated with antibiotics treatment, leading to cycles of repeated infections. Infection can produce diarrhea, abdominal pain, fever, and severe morbidity. In the United States, an estimated 15,000 to 30,000 deaths per year are linked to C. diff. Risk factors for recurrent infection include being 65 or older, hospitalization, being in a nursing home, a weakened immune system, and previous infection with C. diff.

Therapies transplanting fecal microbiota from donors have been used since the 1950s as treatments for recurrent C. diff infection, and in the past decade, as stool banks recruiting screened donors have made fecal microbiota transplants, or FMT, standard of care. However, only in recent years have fecal-derived therapies become subject to standardized safety and efficacy testing.

Both the current FDA-approved products, Rebyota and Vowst, were shown in randomized controlled trials to reduce recurrence of C. diff infection, compared with placebo. In a phase 3 clinical trial of Rebyota (n = 262) in antibiotic-treated patients, one rectally administered dose reduced recurrence of C. diff infection by 70.6% at 8 weeks, compared with 57.5% for placebo. A phase 3 study of Vowst (n = 281) showed recurrence in treated subjects to be 12.4% at 8 weeks, compared with nearly 40% of those receiving placebo (relative risk, 0.32; 95% confidence interval, 0.18-0.58; P less than .001).

Despite screening protocols that have become increasingly homogenized and rigorous, FMT is associated with the risk of introducing pathogens. Vowst is manufactured with purified bacterial spores derived from donor feces, not whole stool. Nonetheless, FDA noted in its statement that Vowst could still potentially introduce infectious agents or allergens.
 

Antibiotics are still first-line treatment

In an interview, Jessica Allegretti, MD, MPH, AGAF, medical director of the Crohn’s and Colitis Center at Brigham & Women’s Hospital, Boston, said that having two FDA-approved therapies with different means of administration “is great for the field and great for patients. These are both meant to be used after a course of antibiotics, so antibiotics are still the mainstay of treatment for C. diff and recurrent C. diff, but we now have more options to prevent recurrence.”

The convenience of an oral therapy that can be taken at home is “very attractive,” Dr. Allegretti added, noting that there will also be patients “who either don’t want to or can’t take capsules, for whom a rectal administration [in a health care setting] may be preferred.”

Dr. Allegretti, who has used FMT to treat recurrent C. difficile for more than a decade, said that she expected traditional FMT using screened donor stool to remain available even as the new products are adopted by clinicians. FMT centers like OpenBiome “will continue to provide access for patients who either don’t have the ability to get the FDA-approved products because of insurance coverage, or for financial reasons, or maybe neither of the new products is appropriate for them,” she said. “I do think there will always be a need for the traditional option. The more options that we have available the better.”

TD Cowen analyst Joseph Thome told Reuters that the drug could be priced close to $20,000 per course, expecting peak sales of $750 million in the U.S. in 2033.

Dr. Allegretti disclosed consulting work for Seres Therapeutics, Ferring, and other manufacturers. She is a member of OpenBiome’s clinical advisory board.

The recent approval of the first oral fecal-derived microbiota therapy to prevent the recurrence of Clostridioides difficile (C. diff) infection in patients was welcome news for physicians who’ve struggled under the weight of having too few treatment options for the prevention of C. diff recurrence.

The product, developed by Massachusetts-based Seres Therepeutics and marketed as Vowst, was approved by the U.S. Food and Drug Administration on April 26. It is approved for use in adults who have already been treated with antibiotics for a recurrent infection with C. diff bacteria.

This is the first oral treatment for the prevention of C. diff recurrence and is designed to be delivered in four capsules taken daily for 3 days.

Gastroenterologist Phillip I. Tarr, MD, division chief of gastroenterology at Washington University, St. Louis, and chair of the American Gastroenterological Association Center for Gut Microbiome Research and Education, said that prevention of recurrent C. diff infection “remains challenging,” and that Vowst “provides the first FDA-approved, orally administered microbiome therapeutic with which to achieve this goal. This advance also makes us optimistic we might soon be able to prevent other disorders by managing gut microbial communities.”

Vowst is the second therapy derived from human stool to be approved for the indication in less than 6 months. In December, the FDA approved Rebyota (Ferring), a rectally delivered treatment that also uses microbes from donor feces. Both products were given priority review, orphan drug, and breakthrough therapy designations by the agency.

C. diff infection can be aggravated by an alteration of normal gut flora associated with antibiotics treatment, leading to cycles of repeated infections. Infection can produce diarrhea, abdominal pain, fever, and severe morbidity. In the United States, an estimated 15,000 to 30,000 deaths per year are linked to C. diff. Risk factors for recurrent infection include being 65 or older, hospitalization, being in a nursing home, a weakened immune system, and previous infection with C. diff.

Therapies transplanting fecal microbiota from donors have been used since the 1950s as treatments for recurrent C. diff infection, and in the past decade, as stool banks recruiting screened donors have made fecal microbiota transplants, or FMT, standard of care. However, only in recent years have fecal-derived therapies become subject to standardized safety and efficacy testing.

Both the current FDA-approved products, Rebyota and Vowst, were shown in randomized controlled trials to reduce recurrence of C. diff infection, compared with placebo. In a phase 3 clinical trial of Rebyota (n = 262) in antibiotic-treated patients, one rectally administered dose reduced recurrence of C. diff infection by 70.6% at 8 weeks, compared with 57.5% for placebo. A phase 3 study of Vowst (n = 281) showed recurrence in treated subjects to be 12.4% at 8 weeks, compared with nearly 40% of those receiving placebo (relative risk, 0.32; 95% confidence interval, 0.18-0.58; P less than .001).

Despite screening protocols that have become increasingly homogenized and rigorous, FMT is associated with the risk of introducing pathogens. Vowst is manufactured with purified bacterial spores derived from donor feces, not whole stool. Nonetheless, FDA noted in its statement that Vowst could still potentially introduce infectious agents or allergens.
 

Antibiotics are still first-line treatment

In an interview, Jessica Allegretti, MD, MPH, AGAF, medical director of the Crohn’s and Colitis Center at Brigham & Women’s Hospital, Boston, said that having two FDA-approved therapies with different means of administration “is great for the field and great for patients. These are both meant to be used after a course of antibiotics, so antibiotics are still the mainstay of treatment for C. diff and recurrent C. diff, but we now have more options to prevent recurrence.”

The convenience of an oral therapy that can be taken at home is “very attractive,” Dr. Allegretti added, noting that there will also be patients “who either don’t want to or can’t take capsules, for whom a rectal administration [in a health care setting] may be preferred.”

Dr. Allegretti, who has used FMT to treat recurrent C. difficile for more than a decade, said that she expected traditional FMT using screened donor stool to remain available even as the new products are adopted by clinicians. FMT centers like OpenBiome “will continue to provide access for patients who either don’t have the ability to get the FDA-approved products because of insurance coverage, or for financial reasons, or maybe neither of the new products is appropriate for them,” she said. “I do think there will always be a need for the traditional option. The more options that we have available the better.”

TD Cowen analyst Joseph Thome told Reuters that the drug could be priced close to $20,000 per course, expecting peak sales of $750 million in the U.S. in 2033.

Dr. Allegretti disclosed consulting work for Seres Therapeutics, Ferring, and other manufacturers. She is a member of OpenBiome’s clinical advisory board.

The Food and Drug Administration has approved injectable poly-L-lactic acid (PLLA-SCA) for the correction of fine lines and wrinkles in the cheek, the manufacturer announced on April 26.

The treatment, marketed as Sculptra, is the first FDA-approved PLLA collagen stimulator that, “when injected into the cheek area, helps stimulate natural collagen production to smooth wrinkles and improve skin quality such as firmness and glow,” according to a press release from the manufacturer, Galderma. Sculptra was first approved for aesthetic use in 2009 in the United States and is now available in more than 40 countries.

Olivier Le Moal/Getty Images

With this expanded approval, PLLA-SCA is now indicated for use in people with healthy immune systems for correcting shallow to deep nasolabial fold contour deficiencies, fine lines, and wrinkles in the cheeks and other facial areas.
 

94% have enduring improvement at 2 years

In a clinical trial, PLLA-SCA achieved the primary efficacy endpoint of at least a 1-grade improvement in wrinkles on both cheeks concurrently at rest and its secondary endpoint of improving cheek wrinkles when smiling for up to 2 years, the company states.

According to Galderma, patients showed aesthetic improvement in cheek wrinkles throughout the study; 96% showed improvement at 3 months, 94% showed improvement at 1 year, and 94% showed improvement at 2 years.

The most common side effects after initial treatment are injection site swelling, tenderness, redness, pain, bruising, bleeding, itching, and lumps, according to the company. Other side effects may include small lumps under the skin that are sometimes noticeable when pressing on the treated area. 

PLLA-SCA is available only through a licensed practitioner and should not be used by people allergic to any ingredient of the product or who have a history of keloid formation or hypertrophic scarring. The company notes that safety has not been established in patients who are pregnant, lactating, breastfeeding, or younger than 18.

In its instruction to clinicians, the company warns the treatment should not be injected into the blood vessels “as it may cause vascular occlusion, infarction, or embolic phenomena.”

Skin sores, cysts, pimples, rashes, hives, or infection should be healed completely before injecting the treatment, the company cautions. PLLA-SCA should not be injected into the red area of the lip or in the periorbital area.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has approved injectable poly-L-lactic acid (PLLA-SCA) for the correction of fine lines and wrinkles in the cheek, the manufacturer announced on April 26.

The treatment, marketed as Sculptra, is the first FDA-approved PLLA collagen stimulator that, “when injected into the cheek area, helps stimulate natural collagen production to smooth wrinkles and improve skin quality such as firmness and glow,” according to a press release from the manufacturer, Galderma. Sculptra was first approved for aesthetic use in 2009 in the United States and is now available in more than 40 countries.

Olivier Le Moal/Getty Images

With this expanded approval, PLLA-SCA is now indicated for use in people with healthy immune systems for correcting shallow to deep nasolabial fold contour deficiencies, fine lines, and wrinkles in the cheeks and other facial areas.
 

94% have enduring improvement at 2 years

In a clinical trial, PLLA-SCA achieved the primary efficacy endpoint of at least a 1-grade improvement in wrinkles on both cheeks concurrently at rest and its secondary endpoint of improving cheek wrinkles when smiling for up to 2 years, the company states.

According to Galderma, patients showed aesthetic improvement in cheek wrinkles throughout the study; 96% showed improvement at 3 months, 94% showed improvement at 1 year, and 94% showed improvement at 2 years.

The most common side effects after initial treatment are injection site swelling, tenderness, redness, pain, bruising, bleeding, itching, and lumps, according to the company. Other side effects may include small lumps under the skin that are sometimes noticeable when pressing on the treated area. 

PLLA-SCA is available only through a licensed practitioner and should not be used by people allergic to any ingredient of the product or who have a history of keloid formation or hypertrophic scarring. The company notes that safety has not been established in patients who are pregnant, lactating, breastfeeding, or younger than 18.

In its instruction to clinicians, the company warns the treatment should not be injected into the blood vessels “as it may cause vascular occlusion, infarction, or embolic phenomena.”

Skin sores, cysts, pimples, rashes, hives, or infection should be healed completely before injecting the treatment, the company cautions. PLLA-SCA should not be injected into the red area of the lip or in the periorbital area.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has approved injectable poly-L-lactic acid (PLLA-SCA) for the correction of fine lines and wrinkles in the cheek, the manufacturer announced on April 26.

The treatment, marketed as Sculptra, is the first FDA-approved PLLA collagen stimulator that, “when injected into the cheek area, helps stimulate natural collagen production to smooth wrinkles and improve skin quality such as firmness and glow,” according to a press release from the manufacturer, Galderma. Sculptra was first approved for aesthetic use in 2009 in the United States and is now available in more than 40 countries.

Olivier Le Moal/Getty Images

With this expanded approval, PLLA-SCA is now indicated for use in people with healthy immune systems for correcting shallow to deep nasolabial fold contour deficiencies, fine lines, and wrinkles in the cheeks and other facial areas.
 

94% have enduring improvement at 2 years

In a clinical trial, PLLA-SCA achieved the primary efficacy endpoint of at least a 1-grade improvement in wrinkles on both cheeks concurrently at rest and its secondary endpoint of improving cheek wrinkles when smiling for up to 2 years, the company states.

According to Galderma, patients showed aesthetic improvement in cheek wrinkles throughout the study; 96% showed improvement at 3 months, 94% showed improvement at 1 year, and 94% showed improvement at 2 years.

The most common side effects after initial treatment are injection site swelling, tenderness, redness, pain, bruising, bleeding, itching, and lumps, according to the company. Other side effects may include small lumps under the skin that are sometimes noticeable when pressing on the treated area. 

PLLA-SCA is available only through a licensed practitioner and should not be used by people allergic to any ingredient of the product or who have a history of keloid formation or hypertrophic scarring. The company notes that safety has not been established in patients who are pregnant, lactating, breastfeeding, or younger than 18.

In its instruction to clinicians, the company warns the treatment should not be injected into the blood vessels “as it may cause vascular occlusion, infarction, or embolic phenomena.”

Skin sores, cysts, pimples, rashes, hives, or infection should be healed completely before injecting the treatment, the company cautions. PLLA-SCA should not be injected into the red area of the lip or in the periorbital area.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has approved the first treatment that takes a genetics-based approach to slowing or stopping the progression of a rare form of amyotrophic lateral sclerosis (ALS), the debilitating and deadly disease for which there is no cure.
 

Most people with ALS die within 3-5 years of when symptoms appear, usually of respiratory failure.

The newly approved drug, called Qalsody, is made by the Swiss company Biogen. The FDA fast-tracked the approval based on early trial results. The agency said in a news release that its decision was based on the demonstrated ability of the drug to reduce a protein in the blood that is a sign of degeneration of brain and nerve cells.

While the drug was shown to impact the chemical process in the body linked to degeneration, there was no significant change in people’s symptoms during the first 28 weeks that they took the drug, Biogen said in a news release. But the company noted that some patients did see improved functioning after starting treatment.

“I have observed the positive impact Qalsody has on slowing the progression of ALS in people with SOD1 mutations,” Timothy M. Miller, MD, PhD, researcher and codirector of the ALS Center at Washington University in St. Louis, said in a statement released by Biogen. “The FDA’s approval of Qalsody gives me hope that people living with this rare form of ALS could experience a reduction in decline in strength, clinical function, and respiratory function.”

Qalsody is given to people via a spinal injection, with an initial course of three injections every 2 weeks. People then get the injection once every 28 days.

The new treatment is approved only for people with a rare kind of ALS called SOD1-ALS, which is known for a genetic mutation. While ALS affects up to 32,000 people in the United States, just 2% of people with ALS have the SOD1 gene mutation. The FDA says the number of people in the United States who could use Qalsody is about 500.

In trials, 147 people received either Qalsody or a placebo, and the treatment significantly reduced the level of a protein in people’s blood that is associated with the loss of control of voluntary muscles. 

Because Qalsody received a fast-track approval from the FDA, it must still provide more research data in the future, including from a trial examining how the drug affects people who carry the SOD1 gene but do not yet show symptoms of ALS.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has approved the first treatment that takes a genetics-based approach to slowing or stopping the progression of a rare form of amyotrophic lateral sclerosis (ALS), the debilitating and deadly disease for which there is no cure.
 

Most people with ALS die within 3-5 years of when symptoms appear, usually of respiratory failure.

The newly approved drug, called Qalsody, is made by the Swiss company Biogen. The FDA fast-tracked the approval based on early trial results. The agency said in a news release that its decision was based on the demonstrated ability of the drug to reduce a protein in the blood that is a sign of degeneration of brain and nerve cells.

While the drug was shown to impact the chemical process in the body linked to degeneration, there was no significant change in people’s symptoms during the first 28 weeks that they took the drug, Biogen said in a news release. But the company noted that some patients did see improved functioning after starting treatment.

“I have observed the positive impact Qalsody has on slowing the progression of ALS in people with SOD1 mutations,” Timothy M. Miller, MD, PhD, researcher and codirector of the ALS Center at Washington University in St. Louis, said in a statement released by Biogen. “The FDA’s approval of Qalsody gives me hope that people living with this rare form of ALS could experience a reduction in decline in strength, clinical function, and respiratory function.”

Qalsody is given to people via a spinal injection, with an initial course of three injections every 2 weeks. People then get the injection once every 28 days.

The new treatment is approved only for people with a rare kind of ALS called SOD1-ALS, which is known for a genetic mutation. While ALS affects up to 32,000 people in the United States, just 2% of people with ALS have the SOD1 gene mutation. The FDA says the number of people in the United States who could use Qalsody is about 500.

In trials, 147 people received either Qalsody or a placebo, and the treatment significantly reduced the level of a protein in people’s blood that is associated with the loss of control of voluntary muscles. 

Because Qalsody received a fast-track approval from the FDA, it must still provide more research data in the future, including from a trial examining how the drug affects people who carry the SOD1 gene but do not yet show symptoms of ALS.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has approved the first treatment that takes a genetics-based approach to slowing or stopping the progression of a rare form of amyotrophic lateral sclerosis (ALS), the debilitating and deadly disease for which there is no cure.
 

Most people with ALS die within 3-5 years of when symptoms appear, usually of respiratory failure.

The newly approved drug, called Qalsody, is made by the Swiss company Biogen. The FDA fast-tracked the approval based on early trial results. The agency said in a news release that its decision was based on the demonstrated ability of the drug to reduce a protein in the blood that is a sign of degeneration of brain and nerve cells.

While the drug was shown to impact the chemical process in the body linked to degeneration, there was no significant change in people’s symptoms during the first 28 weeks that they took the drug, Biogen said in a news release. But the company noted that some patients did see improved functioning after starting treatment.

“I have observed the positive impact Qalsody has on slowing the progression of ALS in people with SOD1 mutations,” Timothy M. Miller, MD, PhD, researcher and codirector of the ALS Center at Washington University in St. Louis, said in a statement released by Biogen. “The FDA’s approval of Qalsody gives me hope that people living with this rare form of ALS could experience a reduction in decline in strength, clinical function, and respiratory function.”

Qalsody is given to people via a spinal injection, with an initial course of three injections every 2 weeks. People then get the injection once every 28 days.

The new treatment is approved only for people with a rare kind of ALS called SOD1-ALS, which is known for a genetic mutation. While ALS affects up to 32,000 people in the United States, just 2% of people with ALS have the SOD1 gene mutation. The FDA says the number of people in the United States who could use Qalsody is about 500.

In trials, 147 people received either Qalsody or a placebo, and the treatment significantly reduced the level of a protein in people’s blood that is associated with the loss of control of voluntary muscles. 

Because Qalsody received a fast-track approval from the FDA, it must still provide more research data in the future, including from a trial examining how the drug affects people who carry the SOD1 gene but do not yet show symptoms of ALS.

A version of this article first appeared on Medscape.com.

The Centers for Disease Control and Prevention has endorsed a plan to “allow” people over age 65 and those who are immunocompromised to get a second dose of the COVID-19 bivalent booster.

This backs the Food and Drug Administration’s authorization April 18 of the additional shot.

“Following FDA regulatory action, CDC has taken steps to simplify COVID-19 vaccine recommendations and allow more flexibility for people at higher risk who want the option of added protection from additional COVID-19 vaccine doses,” the CDC said in a statement.

The agency is following the recommendations made by its Advisory Committee on Immunization Practices (ACIP). While there was no vote, the group reaffirmed its commitment to boosters overall, proposing that all Americans over age 6 who have not had a bivalent mRNA COVID-19 booster vaccine go ahead and get one.

But most others who’ve already had the bivalent shot – which targets the original COVID strain and the two Omicron variants BA.4 and BA.5 – should wait until the fall to get whatever updated vaccine is available.

The panel did carve out exceptions for people over age 65 and those who are immunocompromised because they are at higher risk for severe COVID-19 complications, Evelyn Twentyman, MD, MPH, the lead official in the CDC’s COVID-19 Vaccine Policy Unit, said during the meeting.

People over 65 can now choose to get a second bivalent mRNA booster shot as long as it has been at least 4 months since the last one, she said, and people who are immunocompromised also should have the flexibility to receive one or more additional bivalent boosters at least 2 months after an initial dose.

Regardless of whether someone is unvaccinated, and regardless of how many single-strain COVID vaccines an individual has previously received, they should get a mRNA bivalent shot, Dr. Twentyman said.

If an individual has already received a bivalent mRNA booster – made by either Pfizer/BioNTech or Moderna – “your vaccination is complete,” she said. “No doses indicated at this time, come back and see us in autumn of 2023.”

The CDC is trying to encourage more people to get the updated COVID shot, as just 17% of Americans of any age have received a bivalent booster and only 43% of those age 65 and over.

The CDC followed the FDA’s lead in its statement, phasing out the original single-strain COVID vaccine, saying it will no longer be recommended for use in the United States.
 

‘Unnecessary drama’ over children’s recs

The CDC panel mostly followed the FDA’s guidance on who should get a booster, but many ACIP members expressed consternation and confusion about what was being recommended for children.

For children aged 6 months to 4 years, the CDC will offer tables to help physicians determine how many bivalent doses to give, depending on the child’s vaccination history.

All children those ages should get at least two vaccine doses, one of which is bivalent, Dr. Twentyman said. For children in that age group who have already received a monovalent series and a bivalent dose, “their vaccination is complete,” she said.

For 5-year-olds, the recommendations will be similar if they received a Pfizer monovalent series, but the shot regimen will have to be customized if they had previously received a Moderna shot, because of differences in the dosages.

ACIP member Sarah S. Long, MD, professor of pediatrics, Drexel University, Philadelphia, said that it was unclear why a set age couldn’t be established for COVID-19 vaccination as it had been for other immunizations.

“We picked 60 months for most immunizations in children,” Dr. Long said. “Immunologically there is not a difference between a 4-, a 5- and a 6-year-old.

“There isn’t a reason to have all this unnecessary drama around those ages,” she said, adding that having the different ages would make it harder for pediatricians to appropriately stock vaccines.

Dr. Twentyman said that the CDC would be providing more detailed guidance on its COVID-19 website soon and would be holding a call with health care professionals to discuss the updated recommendations on May 11.
 

New vaccine by fall

CDC and ACIP members both said they hoped to have an even simpler vaccine schedule by the fall, when it is anticipated that the FDA may have authorized a new, updated bivalent vaccine that targets other COVID variants.

“We all recognize this is a work in progress,” said ACIP Chair Grace M. Lee, MD, MPH, acknowledging that there is continued confusion over COVID-19 vaccination.

“The goal really is to try to simplify things over time to be able to help communicate with our provider community, and our patients and families what vaccine is right for them, when do they need it, and how often should they get it,” said Dr. Lee, professor of pediatrics, Stanford (Calif.) University.
 

A version of this article originally appeared on Medscape.com .

The Centers for Disease Control and Prevention has endorsed a plan to “allow” people over age 65 and those who are immunocompromised to get a second dose of the COVID-19 bivalent booster.

This backs the Food and Drug Administration’s authorization April 18 of the additional shot.

“Following FDA regulatory action, CDC has taken steps to simplify COVID-19 vaccine recommendations and allow more flexibility for people at higher risk who want the option of added protection from additional COVID-19 vaccine doses,” the CDC said in a statement.

The agency is following the recommendations made by its Advisory Committee on Immunization Practices (ACIP). While there was no vote, the group reaffirmed its commitment to boosters overall, proposing that all Americans over age 6 who have not had a bivalent mRNA COVID-19 booster vaccine go ahead and get one.

But most others who’ve already had the bivalent shot – which targets the original COVID strain and the two Omicron variants BA.4 and BA.5 – should wait until the fall to get whatever updated vaccine is available.

The panel did carve out exceptions for people over age 65 and those who are immunocompromised because they are at higher risk for severe COVID-19 complications, Evelyn Twentyman, MD, MPH, the lead official in the CDC’s COVID-19 Vaccine Policy Unit, said during the meeting.

People over 65 can now choose to get a second bivalent mRNA booster shot as long as it has been at least 4 months since the last one, she said, and people who are immunocompromised also should have the flexibility to receive one or more additional bivalent boosters at least 2 months after an initial dose.

Regardless of whether someone is unvaccinated, and regardless of how many single-strain COVID vaccines an individual has previously received, they should get a mRNA bivalent shot, Dr. Twentyman said.

If an individual has already received a bivalent mRNA booster – made by either Pfizer/BioNTech or Moderna – “your vaccination is complete,” she said. “No doses indicated at this time, come back and see us in autumn of 2023.”

The CDC is trying to encourage more people to get the updated COVID shot, as just 17% of Americans of any age have received a bivalent booster and only 43% of those age 65 and over.

The CDC followed the FDA’s lead in its statement, phasing out the original single-strain COVID vaccine, saying it will no longer be recommended for use in the United States.
 

‘Unnecessary drama’ over children’s recs

The CDC panel mostly followed the FDA’s guidance on who should get a booster, but many ACIP members expressed consternation and confusion about what was being recommended for children.

For children aged 6 months to 4 years, the CDC will offer tables to help physicians determine how many bivalent doses to give, depending on the child’s vaccination history.

All children those ages should get at least two vaccine doses, one of which is bivalent, Dr. Twentyman said. For children in that age group who have already received a monovalent series and a bivalent dose, “their vaccination is complete,” she said.

For 5-year-olds, the recommendations will be similar if they received a Pfizer monovalent series, but the shot regimen will have to be customized if they had previously received a Moderna shot, because of differences in the dosages.

ACIP member Sarah S. Long, MD, professor of pediatrics, Drexel University, Philadelphia, said that it was unclear why a set age couldn’t be established for COVID-19 vaccination as it had been for other immunizations.

“We picked 60 months for most immunizations in children,” Dr. Long said. “Immunologically there is not a difference between a 4-, a 5- and a 6-year-old.

“There isn’t a reason to have all this unnecessary drama around those ages,” she said, adding that having the different ages would make it harder for pediatricians to appropriately stock vaccines.

Dr. Twentyman said that the CDC would be providing more detailed guidance on its COVID-19 website soon and would be holding a call with health care professionals to discuss the updated recommendations on May 11.
 

New vaccine by fall

CDC and ACIP members both said they hoped to have an even simpler vaccine schedule by the fall, when it is anticipated that the FDA may have authorized a new, updated bivalent vaccine that targets other COVID variants.

“We all recognize this is a work in progress,” said ACIP Chair Grace M. Lee, MD, MPH, acknowledging that there is continued confusion over COVID-19 vaccination.

“The goal really is to try to simplify things over time to be able to help communicate with our provider community, and our patients and families what vaccine is right for them, when do they need it, and how often should they get it,” said Dr. Lee, professor of pediatrics, Stanford (Calif.) University.
 

A version of this article originally appeared on Medscape.com .

The Centers for Disease Control and Prevention has endorsed a plan to “allow” people over age 65 and those who are immunocompromised to get a second dose of the COVID-19 bivalent booster.

This backs the Food and Drug Administration’s authorization April 18 of the additional shot.

“Following FDA regulatory action, CDC has taken steps to simplify COVID-19 vaccine recommendations and allow more flexibility for people at higher risk who want the option of added protection from additional COVID-19 vaccine doses,” the CDC said in a statement.

The agency is following the recommendations made by its Advisory Committee on Immunization Practices (ACIP). While there was no vote, the group reaffirmed its commitment to boosters overall, proposing that all Americans over age 6 who have not had a bivalent mRNA COVID-19 booster vaccine go ahead and get one.

But most others who’ve already had the bivalent shot – which targets the original COVID strain and the two Omicron variants BA.4 and BA.5 – should wait until the fall to get whatever updated vaccine is available.

The panel did carve out exceptions for people over age 65 and those who are immunocompromised because they are at higher risk for severe COVID-19 complications, Evelyn Twentyman, MD, MPH, the lead official in the CDC’s COVID-19 Vaccine Policy Unit, said during the meeting.

People over 65 can now choose to get a second bivalent mRNA booster shot as long as it has been at least 4 months since the last one, she said, and people who are immunocompromised also should have the flexibility to receive one or more additional bivalent boosters at least 2 months after an initial dose.

Regardless of whether someone is unvaccinated, and regardless of how many single-strain COVID vaccines an individual has previously received, they should get a mRNA bivalent shot, Dr. Twentyman said.

If an individual has already received a bivalent mRNA booster – made by either Pfizer/BioNTech or Moderna – “your vaccination is complete,” she said. “No doses indicated at this time, come back and see us in autumn of 2023.”

The CDC is trying to encourage more people to get the updated COVID shot, as just 17% of Americans of any age have received a bivalent booster and only 43% of those age 65 and over.

The CDC followed the FDA’s lead in its statement, phasing out the original single-strain COVID vaccine, saying it will no longer be recommended for use in the United States.
 

‘Unnecessary drama’ over children’s recs

The CDC panel mostly followed the FDA’s guidance on who should get a booster, but many ACIP members expressed consternation and confusion about what was being recommended for children.

For children aged 6 months to 4 years, the CDC will offer tables to help physicians determine how many bivalent doses to give, depending on the child’s vaccination history.

All children those ages should get at least two vaccine doses, one of which is bivalent, Dr. Twentyman said. For children in that age group who have already received a monovalent series and a bivalent dose, “their vaccination is complete,” she said.

For 5-year-olds, the recommendations will be similar if they received a Pfizer monovalent series, but the shot regimen will have to be customized if they had previously received a Moderna shot, because of differences in the dosages.

ACIP member Sarah S. Long, MD, professor of pediatrics, Drexel University, Philadelphia, said that it was unclear why a set age couldn’t be established for COVID-19 vaccination as it had been for other immunizations.

“We picked 60 months for most immunizations in children,” Dr. Long said. “Immunologically there is not a difference between a 4-, a 5- and a 6-year-old.

“There isn’t a reason to have all this unnecessary drama around those ages,” she said, adding that having the different ages would make it harder for pediatricians to appropriately stock vaccines.

Dr. Twentyman said that the CDC would be providing more detailed guidance on its COVID-19 website soon and would be holding a call with health care professionals to discuss the updated recommendations on May 11.
 

New vaccine by fall

CDC and ACIP members both said they hoped to have an even simpler vaccine schedule by the fall, when it is anticipated that the FDA may have authorized a new, updated bivalent vaccine that targets other COVID variants.

“We all recognize this is a work in progress,” said ACIP Chair Grace M. Lee, MD, MPH, acknowledging that there is continued confusion over COVID-19 vaccination.

“The goal really is to try to simplify things over time to be able to help communicate with our provider community, and our patients and families what vaccine is right for them, when do they need it, and how often should they get it,” said Dr. Lee, professor of pediatrics, Stanford (Calif.) University.
 

A version of this article originally appeared on Medscape.com .

More than one in three children and nearly three in five adults take dietary supplements in the United States, a new report shows.

The new figures continue a 15-year trend of small, steady increases in how many people in the United States use the products that can deliver essential nutrients, but their usage includes a risk of getting more nutrients than recommended. In 2007, 48% of adults took supplements, and that figure has reached nearly 59% in this latest count.

The new report looked at whether people took a multivitamin, as well as other more specific supplements. Among children and adolescents aged 19 and under, 23.5% took a multivitamin, while 31.5% of adults reported taking one. The most common specialized supplement that people took was vitamin D.

The report, released by the CDC’s National Center for Health Statistics, compiled survey data from 2017 through 2020 in which 15,548 people reported their household’s usage of dietary supplements. Dietary supplements include vitamins, minerals, herbs, or other botanicals that are taken by mouth in pill, capsule, tablet, or liquid form. The researchers said the vitamin and supplement market is large and growing, totaling $55.7 billion in sales in 2020.

More than one-third of adults (36%) reported taking more than one supplement, and one in four people aged 60 and older said they took four or more.

The data showed demographic trends in who uses dietary supplements. Women and girls were more likely to take supplements than men and boys, although there were similar usage levels for both genders among 1- to 2-year-olds. People with higher education or income levels were more likely to use supplements. Asian people and White people were more likely to take supplements, compared with Hispanic people and Black people.

The authors wrote that monitoring trends in supplement use is important because the products “contribute substantially to nutrient intake as well as increase the risk of excessive intake of certain micronutrients.”

A version of this article originally appeared on WebMD.com.

More than one in three children and nearly three in five adults take dietary supplements in the United States, a new report shows.

The new figures continue a 15-year trend of small, steady increases in how many people in the United States use the products that can deliver essential nutrients, but their usage includes a risk of getting more nutrients than recommended. In 2007, 48% of adults took supplements, and that figure has reached nearly 59% in this latest count.

The new report looked at whether people took a multivitamin, as well as other more specific supplements. Among children and adolescents aged 19 and under, 23.5% took a multivitamin, while 31.5% of adults reported taking one. The most common specialized supplement that people took was vitamin D.

The report, released by the CDC’s National Center for Health Statistics, compiled survey data from 2017 through 2020 in which 15,548 people reported their household’s usage of dietary supplements. Dietary supplements include vitamins, minerals, herbs, or other botanicals that are taken by mouth in pill, capsule, tablet, or liquid form. The researchers said the vitamin and supplement market is large and growing, totaling $55.7 billion in sales in 2020.

More than one-third of adults (36%) reported taking more than one supplement, and one in four people aged 60 and older said they took four or more.

The data showed demographic trends in who uses dietary supplements. Women and girls were more likely to take supplements than men and boys, although there were similar usage levels for both genders among 1- to 2-year-olds. People with higher education or income levels were more likely to use supplements. Asian people and White people were more likely to take supplements, compared with Hispanic people and Black people.

The authors wrote that monitoring trends in supplement use is important because the products “contribute substantially to nutrient intake as well as increase the risk of excessive intake of certain micronutrients.”

A version of this article originally appeared on WebMD.com.

More than one in three children and nearly three in five adults take dietary supplements in the United States, a new report shows.

The new figures continue a 15-year trend of small, steady increases in how many people in the United States use the products that can deliver essential nutrients, but their usage includes a risk of getting more nutrients than recommended. In 2007, 48% of adults took supplements, and that figure has reached nearly 59% in this latest count.

The new report looked at whether people took a multivitamin, as well as other more specific supplements. Among children and adolescents aged 19 and under, 23.5% took a multivitamin, while 31.5% of adults reported taking one. The most common specialized supplement that people took was vitamin D.

The report, released by the CDC’s National Center for Health Statistics, compiled survey data from 2017 through 2020 in which 15,548 people reported their household’s usage of dietary supplements. Dietary supplements include vitamins, minerals, herbs, or other botanicals that are taken by mouth in pill, capsule, tablet, or liquid form. The researchers said the vitamin and supplement market is large and growing, totaling $55.7 billion in sales in 2020.

More than one-third of adults (36%) reported taking more than one supplement, and one in four people aged 60 and older said they took four or more.

The data showed demographic trends in who uses dietary supplements. Women and girls were more likely to take supplements than men and boys, although there were similar usage levels for both genders among 1- to 2-year-olds. People with higher education or income levels were more likely to use supplements. Asian people and White people were more likely to take supplements, compared with Hispanic people and Black people.

The authors wrote that monitoring trends in supplement use is important because the products “contribute substantially to nutrient intake as well as increase the risk of excessive intake of certain micronutrients.”

A version of this article originally appeared on WebMD.com.

The Centers for Disease Control and Prevention has updated its COVID-19 booster shot guidelines to clarify that only a single dose of the latest bivalent booster is recommended at this time. 

“If you have completed your updated booster dose, you are currently up to date. There is not a recommendation to get another updated booster dose,” the CDC website  now explains.

In January, the nation’s expert COVID panel recommended that the United States move toward an annual COVID booster shot in the fall, similar to the annual flu shot, that targets the most widely circulating strains of the virus. Recent studies have shown that booster strength wanes after a few months, spurring discussions of whether people at high risk of getting a severe case of COVID may need more than one annual shot.

September was the last time a new booster dose was recommended, when, at the time, the bivalent  booster was released, offering new protection against Omicron variants of the virus. Health officials’ focus is now shifting from preventing infections to reducing the likelihood of severe ones, the San Francisco Chronicle reported.

“The bottom line is that there is some waning of protection for those who got boosters more than six months ago and haven’t had an intervening infection,” said Bob Wachter, MD, head of the University of California–San Francisco’s department of medicine, according to the Chronicle. “But the level of protection versus severe infection continues to be fairly high, good enough that people who aren’t at super high risk are probably fine waiting until a new booster comes out in the fall.”

The Wall Street Journal reported recently that many people have been asking their doctors to give them another booster, which is not authorized by the Food and Drug Administration. 

About 8 in 10 people in the United States got the initial set of COVID-19 vaccines, which were first approved in August 2021. But just 16.4% of people in the United States have gotten the latest booster that was released in September, CDC data show.  

A version of this article originally appeared on WebMD.com.

The Centers for Disease Control and Prevention has updated its COVID-19 booster shot guidelines to clarify that only a single dose of the latest bivalent booster is recommended at this time. 

“If you have completed your updated booster dose, you are currently up to date. There is not a recommendation to get another updated booster dose,” the CDC website  now explains.

In January, the nation’s expert COVID panel recommended that the United States move toward an annual COVID booster shot in the fall, similar to the annual flu shot, that targets the most widely circulating strains of the virus. Recent studies have shown that booster strength wanes after a few months, spurring discussions of whether people at high risk of getting a severe case of COVID may need more than one annual shot.

September was the last time a new booster dose was recommended, when, at the time, the bivalent  booster was released, offering new protection against Omicron variants of the virus. Health officials’ focus is now shifting from preventing infections to reducing the likelihood of severe ones, the San Francisco Chronicle reported.

“The bottom line is that there is some waning of protection for those who got boosters more than six months ago and haven’t had an intervening infection,” said Bob Wachter, MD, head of the University of California–San Francisco’s department of medicine, according to the Chronicle. “But the level of protection versus severe infection continues to be fairly high, good enough that people who aren’t at super high risk are probably fine waiting until a new booster comes out in the fall.”

The Wall Street Journal reported recently that many people have been asking their doctors to give them another booster, which is not authorized by the Food and Drug Administration. 

About 8 in 10 people in the United States got the initial set of COVID-19 vaccines, which were first approved in August 2021. But just 16.4% of people in the United States have gotten the latest booster that was released in September, CDC data show.  

A version of this article originally appeared on WebMD.com.

The Centers for Disease Control and Prevention has updated its COVID-19 booster shot guidelines to clarify that only a single dose of the latest bivalent booster is recommended at this time. 

“If you have completed your updated booster dose, you are currently up to date. There is not a recommendation to get another updated booster dose,” the CDC website  now explains.

In January, the nation’s expert COVID panel recommended that the United States move toward an annual COVID booster shot in the fall, similar to the annual flu shot, that targets the most widely circulating strains of the virus. Recent studies have shown that booster strength wanes after a few months, spurring discussions of whether people at high risk of getting a severe case of COVID may need more than one annual shot.

September was the last time a new booster dose was recommended, when, at the time, the bivalent  booster was released, offering new protection against Omicron variants of the virus. Health officials’ focus is now shifting from preventing infections to reducing the likelihood of severe ones, the San Francisco Chronicle reported.

“The bottom line is that there is some waning of protection for those who got boosters more than six months ago and haven’t had an intervening infection,” said Bob Wachter, MD, head of the University of California–San Francisco’s department of medicine, according to the Chronicle. “But the level of protection versus severe infection continues to be fairly high, good enough that people who aren’t at super high risk are probably fine waiting until a new booster comes out in the fall.”

The Wall Street Journal reported recently that many people have been asking their doctors to give them another booster, which is not authorized by the Food and Drug Administration. 

About 8 in 10 people in the United States got the initial set of COVID-19 vaccines, which were first approved in August 2021. But just 16.4% of people in the United States have gotten the latest booster that was released in September, CDC data show.  

A version of this article originally appeared on WebMD.com.

The Food and Drug Administration has approved over-the-counter sales of the overdose reversal agent Narcan (naloxone, Emergent BioSolutions). Greater access to the drug should mean more lives saved. However, it’s unclear how much the nasal spray will cost and whether pharmacies will stock the product openly on shelves. 

Currently, major pharmacy chains such as CVS and Walgreens make naloxone available without prescription, but consumers have to ask a pharmacist to dispense the drug.

“The major question is what is it going to cost,” Brian Hurley, MD, MBA, president-elect of the American Society of Addiction Medicine, said in an interview. “In order for people to access it they have to be able to afford it.”

“We won’t accomplish much if people can’t afford to buy Narcan,” said Chuck Ingoglia, president and CEO of the National Council for Mental Wellbeing, in a statement. Still, he applauded the FDA.

“No single approach will end overdose deaths but making Narcan easy to obtain and widely available likely will save countless lives annually,” he said.

“The timeline for availability and price of this OTC product is determined by the manufacturer,” the FDA said in a statement.

Commissioner Robert M. Califf, MD, called for the drug’s manufacturer to “make accessibility to the product a priority by making it available as soon as possible and at an affordable price.”

Emergent BioSolutions did not comment on cost. It said in a statement that the spray “will be available on U.S. shelves and at online retailers by the late summer,” after it has adapted Narcan for direct-to-consumer use, including more consumer-oriented packaging.

Naloxone’s cost varies, depending on geographic location and whether it is generic. According to GoodRX, a box containing two doses of generic naloxone costs $31-$100, depending on location and coupon availability.

A two-dose box of Narcan costs $135-$140. Emergent reported a 14% decline in naloxone sales in 2022 – to $373.7 million – blaming it in part on the introduction of generic formulations.

Dr. Hurley said he expects those who purchase Narcan at a drug store will primarily already be shopping there. It may or may not be those who most often experience overdose, such as people leaving incarceration or experiencing homelessness.

Having Narcan available over-the-counter “is an important supplement but it doesn’t replace the existing array of naloxone distribution programs,” Dr. Hurley said.

The FDA has encouraged naloxone manufacturers to seek OTC approval for the medication since at least 2019, when it designed a model label for a theoretical OTC product.

In November, the agency said it had determined that some naloxone products had the potential to be safe and effective for OTC use and again urged drugmakers to seek such an approval.

Emergent BioSolutions was the first to pursue OTC approval, but another manufacturer – the nonprofit Harm Reduction Therapeutics – is awaiting approval of its application to sell its spray directly to consumers.

Scott Gottlieb, MD, who was the FDA commissioner from 2017 to 2019, said in a tweet that more work needed to be done.

“This regulatory move should be followed by a strong push by elected officials to support wider deployment of Narcan, getting more doses into the hands of at risk households and frontline workers,” he tweeted.

Mr. Ingoglia said that “Narcan represents a second chance. By giving people a second chance, we also give them an opportunity to enter treatment if they so choose. You can’t recover if you’re dead, and we shouldn’t turn our backs on those who may choose a pathway to recovery that includes treatment.”
 

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has approved over-the-counter sales of the overdose reversal agent Narcan (naloxone, Emergent BioSolutions). Greater access to the drug should mean more lives saved. However, it’s unclear how much the nasal spray will cost and whether pharmacies will stock the product openly on shelves. 

Currently, major pharmacy chains such as CVS and Walgreens make naloxone available without prescription, but consumers have to ask a pharmacist to dispense the drug.

“The major question is what is it going to cost,” Brian Hurley, MD, MBA, president-elect of the American Society of Addiction Medicine, said in an interview. “In order for people to access it they have to be able to afford it.”

“We won’t accomplish much if people can’t afford to buy Narcan,” said Chuck Ingoglia, president and CEO of the National Council for Mental Wellbeing, in a statement. Still, he applauded the FDA.

“No single approach will end overdose deaths but making Narcan easy to obtain and widely available likely will save countless lives annually,” he said.

“The timeline for availability and price of this OTC product is determined by the manufacturer,” the FDA said in a statement.

Commissioner Robert M. Califf, MD, called for the drug’s manufacturer to “make accessibility to the product a priority by making it available as soon as possible and at an affordable price.”

Emergent BioSolutions did not comment on cost. It said in a statement that the spray “will be available on U.S. shelves and at online retailers by the late summer,” after it has adapted Narcan for direct-to-consumer use, including more consumer-oriented packaging.

Naloxone’s cost varies, depending on geographic location and whether it is generic. According to GoodRX, a box containing two doses of generic naloxone costs $31-$100, depending on location and coupon availability.

A two-dose box of Narcan costs $135-$140. Emergent reported a 14% decline in naloxone sales in 2022 – to $373.7 million – blaming it in part on the introduction of generic formulations.

Dr. Hurley said he expects those who purchase Narcan at a drug store will primarily already be shopping there. It may or may not be those who most often experience overdose, such as people leaving incarceration or experiencing homelessness.

Having Narcan available over-the-counter “is an important supplement but it doesn’t replace the existing array of naloxone distribution programs,” Dr. Hurley said.

The FDA has encouraged naloxone manufacturers to seek OTC approval for the medication since at least 2019, when it designed a model label for a theoretical OTC product.

In November, the agency said it had determined that some naloxone products had the potential to be safe and effective for OTC use and again urged drugmakers to seek such an approval.

Emergent BioSolutions was the first to pursue OTC approval, but another manufacturer – the nonprofit Harm Reduction Therapeutics – is awaiting approval of its application to sell its spray directly to consumers.

Scott Gottlieb, MD, who was the FDA commissioner from 2017 to 2019, said in a tweet that more work needed to be done.

“This regulatory move should be followed by a strong push by elected officials to support wider deployment of Narcan, getting more doses into the hands of at risk households and frontline workers,” he tweeted.

Mr. Ingoglia said that “Narcan represents a second chance. By giving people a second chance, we also give them an opportunity to enter treatment if they so choose. You can’t recover if you’re dead, and we shouldn’t turn our backs on those who may choose a pathway to recovery that includes treatment.”
 

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has approved over-the-counter sales of the overdose reversal agent Narcan (naloxone, Emergent BioSolutions). Greater access to the drug should mean more lives saved. However, it’s unclear how much the nasal spray will cost and whether pharmacies will stock the product openly on shelves. 

Currently, major pharmacy chains such as CVS and Walgreens make naloxone available without prescription, but consumers have to ask a pharmacist to dispense the drug.

“The major question is what is it going to cost,” Brian Hurley, MD, MBA, president-elect of the American Society of Addiction Medicine, said in an interview. “In order for people to access it they have to be able to afford it.”

“We won’t accomplish much if people can’t afford to buy Narcan,” said Chuck Ingoglia, president and CEO of the National Council for Mental Wellbeing, in a statement. Still, he applauded the FDA.

“No single approach will end overdose deaths but making Narcan easy to obtain and widely available likely will save countless lives annually,” he said.

“The timeline for availability and price of this OTC product is determined by the manufacturer,” the FDA said in a statement.

Commissioner Robert M. Califf, MD, called for the drug’s manufacturer to “make accessibility to the product a priority by making it available as soon as possible and at an affordable price.”

Emergent BioSolutions did not comment on cost. It said in a statement that the spray “will be available on U.S. shelves and at online retailers by the late summer,” after it has adapted Narcan for direct-to-consumer use, including more consumer-oriented packaging.

Naloxone’s cost varies, depending on geographic location and whether it is generic. According to GoodRX, a box containing two doses of generic naloxone costs $31-$100, depending on location and coupon availability.

A two-dose box of Narcan costs $135-$140. Emergent reported a 14% decline in naloxone sales in 2022 – to $373.7 million – blaming it in part on the introduction of generic formulations.

Dr. Hurley said he expects those who purchase Narcan at a drug store will primarily already be shopping there. It may or may not be those who most often experience overdose, such as people leaving incarceration or experiencing homelessness.

Having Narcan available over-the-counter “is an important supplement but it doesn’t replace the existing array of naloxone distribution programs,” Dr. Hurley said.

The FDA has encouraged naloxone manufacturers to seek OTC approval for the medication since at least 2019, when it designed a model label for a theoretical OTC product.

In November, the agency said it had determined that some naloxone products had the potential to be safe and effective for OTC use and again urged drugmakers to seek such an approval.

Emergent BioSolutions was the first to pursue OTC approval, but another manufacturer – the nonprofit Harm Reduction Therapeutics – is awaiting approval of its application to sell its spray directly to consumers.

Scott Gottlieb, MD, who was the FDA commissioner from 2017 to 2019, said in a tweet that more work needed to be done.

“This regulatory move should be followed by a strong push by elected officials to support wider deployment of Narcan, getting more doses into the hands of at risk households and frontline workers,” he tweeted.

Mr. Ingoglia said that “Narcan represents a second chance. By giving people a second chance, we also give them an opportunity to enter treatment if they so choose. You can’t recover if you’re dead, and we shouldn’t turn our backs on those who may choose a pathway to recovery that includes treatment.”
 

A version of this article first appeared on Medscape.com.

Pregnancy-related deaths have surged as much as 40% during the pandemic, with the increase entirely linked to COVID-19, according to a pair of recent reports. The rise in deaths was most pronounced among Black mothers.

In 2021, 1,205 women died from pregnancy-related causes, making the year one of the worst for maternal mortality in U.S. history, according to newly released data from the Centers for Disease Control and Prevention. Maternal mortality is defined as occurring during pregnancy, at delivery, or soon after delivery.

COVID was the driver of the increased death rate, according to a study published in the journal Obstetrics & Gynecology. The researchers noted that unvaccinated pregnant people are more likely to get severe COVID, and that prenatal and postnatal care were disrupted during the early part of the pandemic. From July 2021 to March 2023, the rate of women being vaccinated before pregnancy has risen from 22% to 70%, CDC data show.

Maternal mortality rates jumped the most among Black women, who in 2021 had a maternal mortality rate of nearly 70 deaths per 100,000 live births, which was 2.6 times the rate for White women. 

Existing risks based on a mother’s age also increased from 2020 to 2021. The maternal mortality rates by age in 2021 per 100,000 live births were:

• 20.4 for women under age 25.
• 31.3 for women ages 25 to 39.
• 138.5 for women ages 40 and older.

Iffath Abbasi Hoskins, MD, FACOG, president of the American College of Obstetricians and Gynecologists, called the situation “stunning” and “preventable.”

The findings “send a resounding message that maternal health and evidence-based efforts to eliminate racial health inequities need to be, and remain, a top public health priority,” Dr. Hoskins said in a statement.

“The COVID-19 pandemic had a dramatic and tragic effect on maternal death rates, but we cannot let that fact obscure that there was – and still is – already a maternal mortality crisis to compound,” she said.

A version of this article first appeared on WebMD.com.

Pregnancy-related deaths have surged as much as 40% during the pandemic, with the increase entirely linked to COVID-19, according to a pair of recent reports. The rise in deaths was most pronounced among Black mothers.

In 2021, 1,205 women died from pregnancy-related causes, making the year one of the worst for maternal mortality in U.S. history, according to newly released data from the Centers for Disease Control and Prevention. Maternal mortality is defined as occurring during pregnancy, at delivery, or soon after delivery.

COVID was the driver of the increased death rate, according to a study published in the journal Obstetrics & Gynecology. The researchers noted that unvaccinated pregnant people are more likely to get severe COVID, and that prenatal and postnatal care were disrupted during the early part of the pandemic. From July 2021 to March 2023, the rate of women being vaccinated before pregnancy has risen from 22% to 70%, CDC data show.

Maternal mortality rates jumped the most among Black women, who in 2021 had a maternal mortality rate of nearly 70 deaths per 100,000 live births, which was 2.6 times the rate for White women. 

Existing risks based on a mother’s age also increased from 2020 to 2021. The maternal mortality rates by age in 2021 per 100,000 live births were:

• 20.4 for women under age 25.
• 31.3 for women ages 25 to 39.
• 138.5 for women ages 40 and older.

Iffath Abbasi Hoskins, MD, FACOG, president of the American College of Obstetricians and Gynecologists, called the situation “stunning” and “preventable.”

The findings “send a resounding message that maternal health and evidence-based efforts to eliminate racial health inequities need to be, and remain, a top public health priority,” Dr. Hoskins said in a statement.

“The COVID-19 pandemic had a dramatic and tragic effect on maternal death rates, but we cannot let that fact obscure that there was – and still is – already a maternal mortality crisis to compound,” she said.

A version of this article first appeared on WebMD.com.

Pregnancy-related deaths have surged as much as 40% during the pandemic, with the increase entirely linked to COVID-19, according to a pair of recent reports. The rise in deaths was most pronounced among Black mothers.

In 2021, 1,205 women died from pregnancy-related causes, making the year one of the worst for maternal mortality in U.S. history, according to newly released data from the Centers for Disease Control and Prevention. Maternal mortality is defined as occurring during pregnancy, at delivery, or soon after delivery.

COVID was the driver of the increased death rate, according to a study published in the journal Obstetrics & Gynecology. The researchers noted that unvaccinated pregnant people are more likely to get severe COVID, and that prenatal and postnatal care were disrupted during the early part of the pandemic. From July 2021 to March 2023, the rate of women being vaccinated before pregnancy has risen from 22% to 70%, CDC data show.

Maternal mortality rates jumped the most among Black women, who in 2021 had a maternal mortality rate of nearly 70 deaths per 100,000 live births, which was 2.6 times the rate for White women. 

Existing risks based on a mother’s age also increased from 2020 to 2021. The maternal mortality rates by age in 2021 per 100,000 live births were:

• 20.4 for women under age 25.
• 31.3 for women ages 25 to 39.
• 138.5 for women ages 40 and older.

Iffath Abbasi Hoskins, MD, FACOG, president of the American College of Obstetricians and Gynecologists, called the situation “stunning” and “preventable.”

The findings “send a resounding message that maternal health and evidence-based efforts to eliminate racial health inequities need to be, and remain, a top public health priority,” Dr. Hoskins said in a statement.

“The COVID-19 pandemic had a dramatic and tragic effect on maternal death rates, but we cannot let that fact obscure that there was – and still is – already a maternal mortality crisis to compound,” she said.

A version of this article first appeared on WebMD.com.

The Food and Drug Administration has approved a citrate-free, 100 mg/mL formulation of the biosimilar adalimumab-adaz (Hyrimoz), according to a statement from manufacturer Sandoz.

Hyrimoz, a tumor necrosis factor (TNF) blocker that is biosimilar to its reference product Humira, was approved by the FDA in 2018 at a concentration of 50 mg/mL for rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis. The high-concentration formula is indicated for these same conditions.

Wikimedia Commons/FitzColinGerald/Creative Commons License

Sandoz said that it intends to launch the citrate-free formulation in the United States on July 1. It will be one of up to nine other adalimumab biosimilars that are expected to launch in July. On January 31, Amjevita (adalimumab-atto) became the first adalimumab biosimilar to launch in the United States.

The current label for Hyrimoz contains a black box warning emphasizing certain risks, notably the increased risk for serious infections, such as tuberculosis or sepsis, and an increased risk of malignancy, particularly lymphomas.

Adverse effects associated with Hyrimoz with an incidence greater than 10% include upper respiratory infections and sinusitis, injection-site reactions, headache, and rash.

The approval for the high-concentration formulation was based on data from a phase 1 pharmacokinetics bridging study that compared Hyrimoz 50 mg/mL and citrate-free Hyrimoz 100 mg/mL.

“This study met all of the primary objectives, demonstrating comparable pharmacokinetics and showing similar safety and immunogenicity of the Hyrimoz 50 mg/mL and Hyrimoz [100 mg/mL],” according to Sandoz, a division of Novartis.

The approval for Hyrimoz 50 mg/mL in 2018 was based on preclinical and clinical research comparing Hyrimoz and Humira. In a phase 3 trial published in the British Journal of Dermatology, which included adults with clinically stable but active moderate to severe chronic plaque psoriasis, Hyrimoz and Humira showed a similar percentage of patients met the primary endpoint of a 75% reduction or more in Psoriasis Area and Severity Index (PASI 75) score at 16 weeks, compared with baseline (66.8% and 65%, respectively).

A version of this article originally appeared on Medscape.com.

The Food and Drug Administration has approved a citrate-free, 100 mg/mL formulation of the biosimilar adalimumab-adaz (Hyrimoz), according to a statement from manufacturer Sandoz.

Hyrimoz, a tumor necrosis factor (TNF) blocker that is biosimilar to its reference product Humira, was approved by the FDA in 2018 at a concentration of 50 mg/mL for rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis. The high-concentration formula is indicated for these same conditions.

Wikimedia Commons/FitzColinGerald/Creative Commons License

Sandoz said that it intends to launch the citrate-free formulation in the United States on July 1. It will be one of up to nine other adalimumab biosimilars that are expected to launch in July. On January 31, Amjevita (adalimumab-atto) became the first adalimumab biosimilar to launch in the United States.

The current label for Hyrimoz contains a black box warning emphasizing certain risks, notably the increased risk for serious infections, such as tuberculosis or sepsis, and an increased risk of malignancy, particularly lymphomas.

Adverse effects associated with Hyrimoz with an incidence greater than 10% include upper respiratory infections and sinusitis, injection-site reactions, headache, and rash.

The approval for the high-concentration formulation was based on data from a phase 1 pharmacokinetics bridging study that compared Hyrimoz 50 mg/mL and citrate-free Hyrimoz 100 mg/mL.

“This study met all of the primary objectives, demonstrating comparable pharmacokinetics and showing similar safety and immunogenicity of the Hyrimoz 50 mg/mL and Hyrimoz [100 mg/mL],” according to Sandoz, a division of Novartis.

The approval for Hyrimoz 50 mg/mL in 2018 was based on preclinical and clinical research comparing Hyrimoz and Humira. In a phase 3 trial published in the British Journal of Dermatology, which included adults with clinically stable but active moderate to severe chronic plaque psoriasis, Hyrimoz and Humira showed a similar percentage of patients met the primary endpoint of a 75% reduction or more in Psoriasis Area and Severity Index (PASI 75) score at 16 weeks, compared with baseline (66.8% and 65%, respectively).

A version of this article originally appeared on Medscape.com.

The Food and Drug Administration has approved a citrate-free, 100 mg/mL formulation of the biosimilar adalimumab-adaz (Hyrimoz), according to a statement from manufacturer Sandoz.

Hyrimoz, a tumor necrosis factor (TNF) blocker that is biosimilar to its reference product Humira, was approved by the FDA in 2018 at a concentration of 50 mg/mL for rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis. The high-concentration formula is indicated for these same conditions.

Wikimedia Commons/FitzColinGerald/Creative Commons License

Sandoz said that it intends to launch the citrate-free formulation in the United States on July 1. It will be one of up to nine other adalimumab biosimilars that are expected to launch in July. On January 31, Amjevita (adalimumab-atto) became the first adalimumab biosimilar to launch in the United States.

The current label for Hyrimoz contains a black box warning emphasizing certain risks, notably the increased risk for serious infections, such as tuberculosis or sepsis, and an increased risk of malignancy, particularly lymphomas.

Adverse effects associated with Hyrimoz with an incidence greater than 10% include upper respiratory infections and sinusitis, injection-site reactions, headache, and rash.

The approval for the high-concentration formulation was based on data from a phase 1 pharmacokinetics bridging study that compared Hyrimoz 50 mg/mL and citrate-free Hyrimoz 100 mg/mL.

“This study met all of the primary objectives, demonstrating comparable pharmacokinetics and showing similar safety and immunogenicity of the Hyrimoz 50 mg/mL and Hyrimoz [100 mg/mL],” according to Sandoz, a division of Novartis.

The approval for Hyrimoz 50 mg/mL in 2018 was based on preclinical and clinical research comparing Hyrimoz and Humira. In a phase 3 trial published in the British Journal of Dermatology, which included adults with clinically stable but active moderate to severe chronic plaque psoriasis, Hyrimoz and Humira showed a similar percentage of patients met the primary endpoint of a 75% reduction or more in Psoriasis Area and Severity Index (PASI 75) score at 16 weeks, compared with baseline (66.8% and 65%, respectively).

A version of this article originally appeared on Medscape.com.

A radioligand treatment approved for certain men with metastatic castration-resistant prostate cancer is in short supply because of manufacturing and delivery issues, according to the Food and Drug Administration. 

The therapy lutetium Lu 177 vipivotide tetraxetan (Pluvicto), approved in March 2022, will remain in limited supply until the drug’s manufacturer, Novartis, can ramp up production of the drug over the next 12 months.

In a letter in February, Novartis said it is giving priority to patients who have already started the regimen so they can “appropriately complete their course of therapy.” The manufacturer will not be taking any orders for new patients over the next 4-6 months, as they work to increase supply.

“We are operating our production site at full capacity to treat as many patients as possible, as quickly as possible,” Novartis said. “However, with a nuclear medicine like Pluvicto, there is no backup supply that we can draw from when we experience a delay.”

Pluvicto is currently made in small batches in the company’s manufacturing facility in Italy. The drug only has a 5-day window to reach its intended patient, after which time it cannot be used. Any disruption in the production or shipping process can create a delay.

Novartis said the facility in Italy is currently operating at full capacity and the company is “working to increase production capacity and supply” of the drug over the next 12 months at two new manufacturing sites in the United States. 

The company also encountered supply problems with Pluvicto in 2022 after quality issues were discovered in the manufacturing process.

Currently, patients who are waiting for their first dose of Pluvicto will need to be rescheduled. The manufacturer will be reaching out to health care professionals with options for rescheduling.

Jonathan McConathy, MD, PhD, told The Wall Street Journal that “people will die from this shortage, for sure.”

Dr. McConathy, a radiologist at the University of Alabama at Birmingham who has consulted for Novartis, explained that some patients who would have benefited from the drug likely won’t receive it in time.

A version of this article first appeared on Medscape.com.

A radioligand treatment approved for certain men with metastatic castration-resistant prostate cancer is in short supply because of manufacturing and delivery issues, according to the Food and Drug Administration. 

The therapy lutetium Lu 177 vipivotide tetraxetan (Pluvicto), approved in March 2022, will remain in limited supply until the drug’s manufacturer, Novartis, can ramp up production of the drug over the next 12 months.

In a letter in February, Novartis said it is giving priority to patients who have already started the regimen so they can “appropriately complete their course of therapy.” The manufacturer will not be taking any orders for new patients over the next 4-6 months, as they work to increase supply.

“We are operating our production site at full capacity to treat as many patients as possible, as quickly as possible,” Novartis said. “However, with a nuclear medicine like Pluvicto, there is no backup supply that we can draw from when we experience a delay.”

Pluvicto is currently made in small batches in the company’s manufacturing facility in Italy. The drug only has a 5-day window to reach its intended patient, after which time it cannot be used. Any disruption in the production or shipping process can create a delay.

Novartis said the facility in Italy is currently operating at full capacity and the company is “working to increase production capacity and supply” of the drug over the next 12 months at two new manufacturing sites in the United States. 

The company also encountered supply problems with Pluvicto in 2022 after quality issues were discovered in the manufacturing process.

Currently, patients who are waiting for their first dose of Pluvicto will need to be rescheduled. The manufacturer will be reaching out to health care professionals with options for rescheduling.

Jonathan McConathy, MD, PhD, told The Wall Street Journal that “people will die from this shortage, for sure.”

Dr. McConathy, a radiologist at the University of Alabama at Birmingham who has consulted for Novartis, explained that some patients who would have benefited from the drug likely won’t receive it in time.

A version of this article first appeared on Medscape.com.

A radioligand treatment approved for certain men with metastatic castration-resistant prostate cancer is in short supply because of manufacturing and delivery issues, according to the Food and Drug Administration. 

The therapy lutetium Lu 177 vipivotide tetraxetan (Pluvicto), approved in March 2022, will remain in limited supply until the drug’s manufacturer, Novartis, can ramp up production of the drug over the next 12 months.

In a letter in February, Novartis said it is giving priority to patients who have already started the regimen so they can “appropriately complete their course of therapy.” The manufacturer will not be taking any orders for new patients over the next 4-6 months, as they work to increase supply.

“We are operating our production site at full capacity to treat as many patients as possible, as quickly as possible,” Novartis said. “However, with a nuclear medicine like Pluvicto, there is no backup supply that we can draw from when we experience a delay.”

Pluvicto is currently made in small batches in the company’s manufacturing facility in Italy. The drug only has a 5-day window to reach its intended patient, after which time it cannot be used. Any disruption in the production or shipping process can create a delay.

Novartis said the facility in Italy is currently operating at full capacity and the company is “working to increase production capacity and supply” of the drug over the next 12 months at two new manufacturing sites in the United States. 

The company also encountered supply problems with Pluvicto in 2022 after quality issues were discovered in the manufacturing process.

Currently, patients who are waiting for their first dose of Pluvicto will need to be rescheduled. The manufacturer will be reaching out to health care professionals with options for rescheduling.

Jonathan McConathy, MD, PhD, told The Wall Street Journal that “people will die from this shortage, for sure.”

Dr. McConathy, a radiologist at the University of Alabama at Birmingham who has consulted for Novartis, explained that some patients who would have benefited from the drug likely won’t receive it in time.

A version of this article first appeared on Medscape.com.