News from the FDA/CDC

The United States Food and Drug Administration has approved the Janus kinase (JAK) inhibitor upadacitinib (Rinvoq) for adults with nonradiographic axial spondyloarthritis (nr-axSpA) who have objective signs of inflammation and who have had an inadequate response to or are intolerant of one or more tumor necrosis factor (TNF) inhibitors, according to an announcement from the manufacturer, AbbVie.

The indication is the sixth in the United States for the JAK inhibitor. Upadacitinib 15 mg once daily is already approved in the United States for adults with moderately to severely active rheumatoid arthritis, active psoriatic arthritis (PsA), and active ankylosing spondylitis (AS). All these indications are for patients who have had an inadequate response to or are intolerant of one or more TNF inhibitors.

Upadacitinib is now the only JAK inhibitor that has been approved for both nr-axSpA and AS.

“Many patients living with nr-axSpA continue to experience symptoms and are unable to control disease with current treatments. In the SELECT-AXIS 2 trials, Rinvoq demonstrated efficacy in both nr-axSpA and AS with safety that was consistent across indications,” Atul Deodhar, MD, lead investigator of the trial, said in the announcement. “Today’s FDA approval offers an important new therapeutic option for patients and their caregivers to help take control of their symptoms and disease.”

Upadacitinib is also approved at a dose of 15 mg once daily for adults and children 12 years of age and older who weigh at least 40 kg and who have refractory, moderate to severe atopic dermatitis that is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable.

It is approved as well at 45 mg once daily for 8 weeks as an induction therapy for adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to or are intolerant of one or more TNF blockers. Following induction therapy for patients with ulcerative colitis, the recommended dose for maintenance treatment is 15 mg once daily, but a dose of 30 mg once daily may be considered for patients with refractory, severe, or extensive disease.

The FDA’s decision is supported by data from the phase 3 SELECT-AXIS 2 clinical trial, which assessed the efficacy, safety, and tolerability of upadacitinib in adults with active nr-axSpA.

Nearly half of patients treated with upadacitinib had achieved 40% improvement in Assessment of Spondyloarthritis International Society response criteria (ASAS 40), the primary endpoint, at week 14, compared with placebo (44.9% vs. 22.3%). These responses were observed as early as 2 weeks after initiation of therapy. The safety profile was consistent with what’s known in patients with RA, PsA, and AS.

Upadacitinib can lower the ability to fight infections. Serious infections, some fatal, have occurred, including tuberculosis and infections caused by bacteria, fungi, or viruses. It is associated with an increased risk of death and major cardiovascular events in people aged 50 and older who have at least one heart disease risk factor, and it is associated with an increased risk of some cancers, including lymphoma and skin cancers.

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

The United States Food and Drug Administration has approved the Janus kinase (JAK) inhibitor upadacitinib (Rinvoq) for adults with nonradiographic axial spondyloarthritis (nr-axSpA) who have objective signs of inflammation and who have had an inadequate response to or are intolerant of one or more tumor necrosis factor (TNF) inhibitors, according to an announcement from the manufacturer, AbbVie.

The indication is the sixth in the United States for the JAK inhibitor. Upadacitinib 15 mg once daily is already approved in the United States for adults with moderately to severely active rheumatoid arthritis, active psoriatic arthritis (PsA), and active ankylosing spondylitis (AS). All these indications are for patients who have had an inadequate response to or are intolerant of one or more TNF inhibitors.

Upadacitinib is now the only JAK inhibitor that has been approved for both nr-axSpA and AS.

“Many patients living with nr-axSpA continue to experience symptoms and are unable to control disease with current treatments. In the SELECT-AXIS 2 trials, Rinvoq demonstrated efficacy in both nr-axSpA and AS with safety that was consistent across indications,” Atul Deodhar, MD, lead investigator of the trial, said in the announcement. “Today’s FDA approval offers an important new therapeutic option for patients and their caregivers to help take control of their symptoms and disease.”

Upadacitinib is also approved at a dose of 15 mg once daily for adults and children 12 years of age and older who weigh at least 40 kg and who have refractory, moderate to severe atopic dermatitis that is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable.

It is approved as well at 45 mg once daily for 8 weeks as an induction therapy for adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to or are intolerant of one or more TNF blockers. Following induction therapy for patients with ulcerative colitis, the recommended dose for maintenance treatment is 15 mg once daily, but a dose of 30 mg once daily may be considered for patients with refractory, severe, or extensive disease.

The FDA’s decision is supported by data from the phase 3 SELECT-AXIS 2 clinical trial, which assessed the efficacy, safety, and tolerability of upadacitinib in adults with active nr-axSpA.

Nearly half of patients treated with upadacitinib had achieved 40% improvement in Assessment of Spondyloarthritis International Society response criteria (ASAS 40), the primary endpoint, at week 14, compared with placebo (44.9% vs. 22.3%). These responses were observed as early as 2 weeks after initiation of therapy. The safety profile was consistent with what’s known in patients with RA, PsA, and AS.

Upadacitinib can lower the ability to fight infections. Serious infections, some fatal, have occurred, including tuberculosis and infections caused by bacteria, fungi, or viruses. It is associated with an increased risk of death and major cardiovascular events in people aged 50 and older who have at least one heart disease risk factor, and it is associated with an increased risk of some cancers, including lymphoma and skin cancers.

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

The United States Food and Drug Administration has approved the Janus kinase (JAK) inhibitor upadacitinib (Rinvoq) for adults with nonradiographic axial spondyloarthritis (nr-axSpA) who have objective signs of inflammation and who have had an inadequate response to or are intolerant of one or more tumor necrosis factor (TNF) inhibitors, according to an announcement from the manufacturer, AbbVie.

The indication is the sixth in the United States for the JAK inhibitor. Upadacitinib 15 mg once daily is already approved in the United States for adults with moderately to severely active rheumatoid arthritis, active psoriatic arthritis (PsA), and active ankylosing spondylitis (AS). All these indications are for patients who have had an inadequate response to or are intolerant of one or more TNF inhibitors.

Upadacitinib is now the only JAK inhibitor that has been approved for both nr-axSpA and AS.

“Many patients living with nr-axSpA continue to experience symptoms and are unable to control disease with current treatments. In the SELECT-AXIS 2 trials, Rinvoq demonstrated efficacy in both nr-axSpA and AS with safety that was consistent across indications,” Atul Deodhar, MD, lead investigator of the trial, said in the announcement. “Today’s FDA approval offers an important new therapeutic option for patients and their caregivers to help take control of their symptoms and disease.”

Upadacitinib is also approved at a dose of 15 mg once daily for adults and children 12 years of age and older who weigh at least 40 kg and who have refractory, moderate to severe atopic dermatitis that is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable.

It is approved as well at 45 mg once daily for 8 weeks as an induction therapy for adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to or are intolerant of one or more TNF blockers. Following induction therapy for patients with ulcerative colitis, the recommended dose for maintenance treatment is 15 mg once daily, but a dose of 30 mg once daily may be considered for patients with refractory, severe, or extensive disease.

The FDA’s decision is supported by data from the phase 3 SELECT-AXIS 2 clinical trial, which assessed the efficacy, safety, and tolerability of upadacitinib in adults with active nr-axSpA.

Nearly half of patients treated with upadacitinib had achieved 40% improvement in Assessment of Spondyloarthritis International Society response criteria (ASAS 40), the primary endpoint, at week 14, compared with placebo (44.9% vs. 22.3%). These responses were observed as early as 2 weeks after initiation of therapy. The safety profile was consistent with what’s known in patients with RA, PsA, and AS.

Upadacitinib can lower the ability to fight infections. Serious infections, some fatal, have occurred, including tuberculosis and infections caused by bacteria, fungi, or viruses. It is associated with an increased risk of death and major cardiovascular events in people aged 50 and older who have at least one heart disease risk factor, and it is associated with an increased risk of some cancers, including lymphoma and skin cancers.

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

Black Americans are 80% more likely to be hospitalized for the flu, compared with White Americans, according to new federal data.

Black, Hispanic, and American Indian/Alaska Native (AI/AN) adults in the United States also have had lower influenza vaccination rates, compared with their White counterparts, since 2010, researchers at the Centers for Disease Control and Prevention (CDC) revealed in a report.

The inequalities are the result of barriers to care, distrust of the medical system, and misinformation, the report said.

“We have many of the tools we need to address inequities and flu vaccination coverage and outcomes,” said CDC Acting Principal Deputy Director Debra Houry, MD, MPH, in a press call; “however, we must acknowledge that inequities in access to care continue to exist. To improve vaccine uptake, we must address the root causes of these ongoing disparities.”

The CDC has already reported early increases in flu activity in the United States, with the highest activity in the southeastern and south-central parts of the country. Experts also warn of a potentially more severe influenza season than in the previous 2 years. CDC officials emphasized that vaccination is the best protection against severe illness, hospitalization, and death from the flu. “Everyone should get vaccinated against flu today and encourage others and their community to get a flu vaccine for the best protection against flu this fall and winter,” Dr. Houry said.

In the recent report on disparities by community published October 18 in CDC Vital Signs, researchers looked at hospitalization rates from 2009 to 2022 and vaccination rates from 2010 to 2022 based on race and ethnicity using two national databases, the Influenza-Associated Hospitalization Surveillance Network and the Behavioral Risk Factor Surveillance System. All individuals included in the analysis were aged 18 years or older, and the 2020-2021 flu season was excluded from the analysis because of insufficient data.

Compared with those for White adults, hospitalization rates were 80% higher for Black adults, 30% higher for Hispanic adults, and 20% higher for AI/AN adults. While flu vaccination rates were similar in White and Asian adults (about 54%), coverage was lower in Black (42%), Hispanic (38%), AI/AN (41%), and other/multiracial (43%) adults. This disparity persisted even among individuals who had medical insurance, a personal health care provider, and a routine checkup within the last year.

“This report adds to the body of evidence that shows people from certain racial and ethnic minority groups have more severe outcomes at higher rates than White adults,” Carla Black, PhD, MPH, an epidemiologist at the CDC’s Immunization Services Division, said during the press call. While flu vaccines may not always prevent infection, people who do get sick after being vaccinated tend to have better outcomes, she added. The report noted that building trust, increasing access to vaccination services, and combating misinformation are important steps to increasing vaccine coverage in minority groups. 

While social distancing measures such as masking have made it difficult for the flu to spread, the relaxation of these safety measures could also lead to higher case counts. “We’ve had two mild flu seasons, and this means we might be ripe for a severe season,” Dr. Black said. “People haven’t had natural disease in 2 years, so there’s less natural immunity out there. People are going back to work. People are traveling again. All of these factors could contribute to us having a more severe flu season.”

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

Black Americans are 80% more likely to be hospitalized for the flu, compared with White Americans, according to new federal data.

Black, Hispanic, and American Indian/Alaska Native (AI/AN) adults in the United States also have had lower influenza vaccination rates, compared with their White counterparts, since 2010, researchers at the Centers for Disease Control and Prevention (CDC) revealed in a report.

The inequalities are the result of barriers to care, distrust of the medical system, and misinformation, the report said.

“We have many of the tools we need to address inequities and flu vaccination coverage and outcomes,” said CDC Acting Principal Deputy Director Debra Houry, MD, MPH, in a press call; “however, we must acknowledge that inequities in access to care continue to exist. To improve vaccine uptake, we must address the root causes of these ongoing disparities.”

The CDC has already reported early increases in flu activity in the United States, with the highest activity in the southeastern and south-central parts of the country. Experts also warn of a potentially more severe influenza season than in the previous 2 years. CDC officials emphasized that vaccination is the best protection against severe illness, hospitalization, and death from the flu. “Everyone should get vaccinated against flu today and encourage others and their community to get a flu vaccine for the best protection against flu this fall and winter,” Dr. Houry said.

In the recent report on disparities by community published October 18 in CDC Vital Signs, researchers looked at hospitalization rates from 2009 to 2022 and vaccination rates from 2010 to 2022 based on race and ethnicity using two national databases, the Influenza-Associated Hospitalization Surveillance Network and the Behavioral Risk Factor Surveillance System. All individuals included in the analysis were aged 18 years or older, and the 2020-2021 flu season was excluded from the analysis because of insufficient data.

Compared with those for White adults, hospitalization rates were 80% higher for Black adults, 30% higher for Hispanic adults, and 20% higher for AI/AN adults. While flu vaccination rates were similar in White and Asian adults (about 54%), coverage was lower in Black (42%), Hispanic (38%), AI/AN (41%), and other/multiracial (43%) adults. This disparity persisted even among individuals who had medical insurance, a personal health care provider, and a routine checkup within the last year.

“This report adds to the body of evidence that shows people from certain racial and ethnic minority groups have more severe outcomes at higher rates than White adults,” Carla Black, PhD, MPH, an epidemiologist at the CDC’s Immunization Services Division, said during the press call. While flu vaccines may not always prevent infection, people who do get sick after being vaccinated tend to have better outcomes, she added. The report noted that building trust, increasing access to vaccination services, and combating misinformation are important steps to increasing vaccine coverage in minority groups. 

While social distancing measures such as masking have made it difficult for the flu to spread, the relaxation of these safety measures could also lead to higher case counts. “We’ve had two mild flu seasons, and this means we might be ripe for a severe season,” Dr. Black said. “People haven’t had natural disease in 2 years, so there’s less natural immunity out there. People are going back to work. People are traveling again. All of these factors could contribute to us having a more severe flu season.”

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

Black Americans are 80% more likely to be hospitalized for the flu, compared with White Americans, according to new federal data.

Black, Hispanic, and American Indian/Alaska Native (AI/AN) adults in the United States also have had lower influenza vaccination rates, compared with their White counterparts, since 2010, researchers at the Centers for Disease Control and Prevention (CDC) revealed in a report.

The inequalities are the result of barriers to care, distrust of the medical system, and misinformation, the report said.

“We have many of the tools we need to address inequities and flu vaccination coverage and outcomes,” said CDC Acting Principal Deputy Director Debra Houry, MD, MPH, in a press call; “however, we must acknowledge that inequities in access to care continue to exist. To improve vaccine uptake, we must address the root causes of these ongoing disparities.”

The CDC has already reported early increases in flu activity in the United States, with the highest activity in the southeastern and south-central parts of the country. Experts also warn of a potentially more severe influenza season than in the previous 2 years. CDC officials emphasized that vaccination is the best protection against severe illness, hospitalization, and death from the flu. “Everyone should get vaccinated against flu today and encourage others and their community to get a flu vaccine for the best protection against flu this fall and winter,” Dr. Houry said.

In the recent report on disparities by community published October 18 in CDC Vital Signs, researchers looked at hospitalization rates from 2009 to 2022 and vaccination rates from 2010 to 2022 based on race and ethnicity using two national databases, the Influenza-Associated Hospitalization Surveillance Network and the Behavioral Risk Factor Surveillance System. All individuals included in the analysis were aged 18 years or older, and the 2020-2021 flu season was excluded from the analysis because of insufficient data.

Compared with those for White adults, hospitalization rates were 80% higher for Black adults, 30% higher for Hispanic adults, and 20% higher for AI/AN adults. While flu vaccination rates were similar in White and Asian adults (about 54%), coverage was lower in Black (42%), Hispanic (38%), AI/AN (41%), and other/multiracial (43%) adults. This disparity persisted even among individuals who had medical insurance, a personal health care provider, and a routine checkup within the last year.

“This report adds to the body of evidence that shows people from certain racial and ethnic minority groups have more severe outcomes at higher rates than White adults,” Carla Black, PhD, MPH, an epidemiologist at the CDC’s Immunization Services Division, said during the press call. While flu vaccines may not always prevent infection, people who do get sick after being vaccinated tend to have better outcomes, she added. The report noted that building trust, increasing access to vaccination services, and combating misinformation are important steps to increasing vaccine coverage in minority groups. 

While social distancing measures such as masking have made it difficult for the flu to spread, the relaxation of these safety measures could also lead to higher case counts. “We’ve had two mild flu seasons, and this means we might be ripe for a severe season,” Dr. Black said. “People haven’t had natural disease in 2 years, so there’s less natural immunity out there. People are going back to work. People are traveling again. All of these factors could contribute to us having a more severe flu season.”

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

The U.S. Food and Drug Administration has confirmed a nationwide shortage of the immediate release formulation of amphetamine mixed salts (Adderall, Adderall IR), which are approved for treating attention deficit hyperactivity disorder and narcolepsy.

The FDA announcement follows weeks of reports of a shortage of the drug by pharmacy chains and Adderall users.

The agency said it is in “frequent” contact with all manufacturers of Adderall – and reported that one of those companies, Teva, is experiencing ongoing intermittent manufacturing delays.

Other manufacturers continue to produce amphetamine mixed salts, but there is not enough supply to continue to meet U.S. market demand through those producers, the FDA noted.

“Until supply is restored, there are alternative therapies, including the extended-release version of amphetamine mixed salts, available to health care professionals and their patients for amphetamine mixed salts’ approved indications,” the agency said.

Patients should work with their health care provider to determine their best treatment option, it added.

The organization is continuing to monitor the supply of Adderall and to help manufacturers resolve the shortage.

Its Drug Shortage webpage has additional information about the situation and is updated regularly.

“We continue to use all the tools we have available to help keep supply available for patients and will provide public updates regarding the Adderall shortage,” the FDA said.

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

The U.S. Food and Drug Administration has confirmed a nationwide shortage of the immediate release formulation of amphetamine mixed salts (Adderall, Adderall IR), which are approved for treating attention deficit hyperactivity disorder and narcolepsy.

The FDA announcement follows weeks of reports of a shortage of the drug by pharmacy chains and Adderall users.

The agency said it is in “frequent” contact with all manufacturers of Adderall – and reported that one of those companies, Teva, is experiencing ongoing intermittent manufacturing delays.

Other manufacturers continue to produce amphetamine mixed salts, but there is not enough supply to continue to meet U.S. market demand through those producers, the FDA noted.

“Until supply is restored, there are alternative therapies, including the extended-release version of amphetamine mixed salts, available to health care professionals and their patients for amphetamine mixed salts’ approved indications,” the agency said.

Patients should work with their health care provider to determine their best treatment option, it added.

The organization is continuing to monitor the supply of Adderall and to help manufacturers resolve the shortage.

Its Drug Shortage webpage has additional information about the situation and is updated regularly.

“We continue to use all the tools we have available to help keep supply available for patients and will provide public updates regarding the Adderall shortage,” the FDA said.

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

The U.S. Food and Drug Administration has confirmed a nationwide shortage of the immediate release formulation of amphetamine mixed salts (Adderall, Adderall IR), which are approved for treating attention deficit hyperactivity disorder and narcolepsy.

The FDA announcement follows weeks of reports of a shortage of the drug by pharmacy chains and Adderall users.

The agency said it is in “frequent” contact with all manufacturers of Adderall – and reported that one of those companies, Teva, is experiencing ongoing intermittent manufacturing delays.

Other manufacturers continue to produce amphetamine mixed salts, but there is not enough supply to continue to meet U.S. market demand through those producers, the FDA noted.

“Until supply is restored, there are alternative therapies, including the extended-release version of amphetamine mixed salts, available to health care professionals and their patients for amphetamine mixed salts’ approved indications,” the agency said.

Patients should work with their health care provider to determine their best treatment option, it added.

The organization is continuing to monitor the supply of Adderall and to help manufacturers resolve the shortage.

Its Drug Shortage webpage has additional information about the situation and is updated regularly.

“We continue to use all the tools we have available to help keep supply available for patients and will provide public updates regarding the Adderall shortage,” the FDA said.

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

A small increase in new cases brought COVID-19’s latest losing streak to an end at 4 weeks, based on data from the American Academy of Pediatrics and the Children’s Hospital Association.

After the 57% decline in cases seen during those 4 weeks of September, new cases rose by 3.7% during the week of Sept. 30 to Oct. 6. The 40,656 new cases reported bring the U.S. cumulative count of child COVID-19 cases to over 14.8 million since the pandemic began, which represents 18.4% of all cases, the AAP and CHA said in their weekly report based on state-level data.

The increase in new cases was not reflected in emergency department visits or hospital admissions, which both continued sustained declines that started in August. In the week from Sept. 27 to Oct. 4, the 7-day averages for ED visits with diagnosed COVID were down by 21.5% (age 0-11), 27.3% (12-15), and 18.2% (16-17), the Centers for Disease Control and Prevention said, while the most recent 7-day average for new admissions – 127 per day for Oct. 2-8 – among children aged 0-17 years with confirmed COVID was down from 161 per day the previous week, a drop of over 21%.

The state-level data that are currently available (several states are no longer reporting) show Alaska (25.5%) and Vermont (25.4%) have the highest proportions of cumulative cases in children, and Florida (12.3%) and Utah (13.5%) have the lowest. Rhode Island has the highest rate of COVID-19 per 100,000 children at 40,427, while Missouri has the lowest at 14,252. The national average is 19,687 per 100,000, the AAP and CHA reported.
 

Taking a look at vaccination

Vaccinations were up slightly in children aged 12-17 years, as 20,000 initial doses were given during the week of Sept. 29 to Oct. 5, compared with 17,000 and 18,000 the previous 2 weeks. Initial vaccinations in younger children, however, continued declines dating back to August, the AAP said in its weekly vaccination trends report.

The District of Columbia and Massachusetts have the most highly vaccinated groups of 12- to 17-year-olds, as 100% and 95%, respectively, have received initial doses, while Wyoming (39%) and Idaho (42%) have the lowest. D.C. (73%) and Vermont (68%) have the highest proportions of vaccinated 5- to 11-year-olds, and Alabama (17%) and Mississippi (18%) have the lowest. For children under age 5 years, those in D.C. (33%) and Vermont (26%) are the most likely to have received an initial COVID vaccination, while Alabama, Louisiana, and Mississippi share national-low rates of 2%, the AAP said its report, which is based on CDC data.

When all states and territories are combined, 71% of children aged 12-17 have received at least one dose of vaccine, as have 38.6% of all children 5-11 years old and 6.7% of those under age 5. Almost 61% of the nation’s 16- to 17-year-olds have been fully vaccinated, along with 31.5% of those aged 5-11 and 2.4% of children younger than 5 years, the CDC said on its COVID Data Tracker.

About 42 million children – 58% of the population under the age of 18 years – have not received any vaccine yet, the AAP noted. Meanwhile, CDC data indicate that 36 children died of COVID in the last week, with pediatric deaths now totaling 1,781 over the course of the pandemic.

A small increase in new cases brought COVID-19’s latest losing streak to an end at 4 weeks, based on data from the American Academy of Pediatrics and the Children’s Hospital Association.

After the 57% decline in cases seen during those 4 weeks of September, new cases rose by 3.7% during the week of Sept. 30 to Oct. 6. The 40,656 new cases reported bring the U.S. cumulative count of child COVID-19 cases to over 14.8 million since the pandemic began, which represents 18.4% of all cases, the AAP and CHA said in their weekly report based on state-level data.

The increase in new cases was not reflected in emergency department visits or hospital admissions, which both continued sustained declines that started in August. In the week from Sept. 27 to Oct. 4, the 7-day averages for ED visits with diagnosed COVID were down by 21.5% (age 0-11), 27.3% (12-15), and 18.2% (16-17), the Centers for Disease Control and Prevention said, while the most recent 7-day average for new admissions – 127 per day for Oct. 2-8 – among children aged 0-17 years with confirmed COVID was down from 161 per day the previous week, a drop of over 21%.

The state-level data that are currently available (several states are no longer reporting) show Alaska (25.5%) and Vermont (25.4%) have the highest proportions of cumulative cases in children, and Florida (12.3%) and Utah (13.5%) have the lowest. Rhode Island has the highest rate of COVID-19 per 100,000 children at 40,427, while Missouri has the lowest at 14,252. The national average is 19,687 per 100,000, the AAP and CHA reported.
 

Taking a look at vaccination

Vaccinations were up slightly in children aged 12-17 years, as 20,000 initial doses were given during the week of Sept. 29 to Oct. 5, compared with 17,000 and 18,000 the previous 2 weeks. Initial vaccinations in younger children, however, continued declines dating back to August, the AAP said in its weekly vaccination trends report.

The District of Columbia and Massachusetts have the most highly vaccinated groups of 12- to 17-year-olds, as 100% and 95%, respectively, have received initial doses, while Wyoming (39%) and Idaho (42%) have the lowest. D.C. (73%) and Vermont (68%) have the highest proportions of vaccinated 5- to 11-year-olds, and Alabama (17%) and Mississippi (18%) have the lowest. For children under age 5 years, those in D.C. (33%) and Vermont (26%) are the most likely to have received an initial COVID vaccination, while Alabama, Louisiana, and Mississippi share national-low rates of 2%, the AAP said its report, which is based on CDC data.

When all states and territories are combined, 71% of children aged 12-17 have received at least one dose of vaccine, as have 38.6% of all children 5-11 years old and 6.7% of those under age 5. Almost 61% of the nation’s 16- to 17-year-olds have been fully vaccinated, along with 31.5% of those aged 5-11 and 2.4% of children younger than 5 years, the CDC said on its COVID Data Tracker.

About 42 million children – 58% of the population under the age of 18 years – have not received any vaccine yet, the AAP noted. Meanwhile, CDC data indicate that 36 children died of COVID in the last week, with pediatric deaths now totaling 1,781 over the course of the pandemic.

A small increase in new cases brought COVID-19’s latest losing streak to an end at 4 weeks, based on data from the American Academy of Pediatrics and the Children’s Hospital Association.

After the 57% decline in cases seen during those 4 weeks of September, new cases rose by 3.7% during the week of Sept. 30 to Oct. 6. The 40,656 new cases reported bring the U.S. cumulative count of child COVID-19 cases to over 14.8 million since the pandemic began, which represents 18.4% of all cases, the AAP and CHA said in their weekly report based on state-level data.

The increase in new cases was not reflected in emergency department visits or hospital admissions, which both continued sustained declines that started in August. In the week from Sept. 27 to Oct. 4, the 7-day averages for ED visits with diagnosed COVID were down by 21.5% (age 0-11), 27.3% (12-15), and 18.2% (16-17), the Centers for Disease Control and Prevention said, while the most recent 7-day average for new admissions – 127 per day for Oct. 2-8 – among children aged 0-17 years with confirmed COVID was down from 161 per day the previous week, a drop of over 21%.

The state-level data that are currently available (several states are no longer reporting) show Alaska (25.5%) and Vermont (25.4%) have the highest proportions of cumulative cases in children, and Florida (12.3%) and Utah (13.5%) have the lowest. Rhode Island has the highest rate of COVID-19 per 100,000 children at 40,427, while Missouri has the lowest at 14,252. The national average is 19,687 per 100,000, the AAP and CHA reported.
 

Taking a look at vaccination

Vaccinations were up slightly in children aged 12-17 years, as 20,000 initial doses were given during the week of Sept. 29 to Oct. 5, compared with 17,000 and 18,000 the previous 2 weeks. Initial vaccinations in younger children, however, continued declines dating back to August, the AAP said in its weekly vaccination trends report.

The District of Columbia and Massachusetts have the most highly vaccinated groups of 12- to 17-year-olds, as 100% and 95%, respectively, have received initial doses, while Wyoming (39%) and Idaho (42%) have the lowest. D.C. (73%) and Vermont (68%) have the highest proportions of vaccinated 5- to 11-year-olds, and Alabama (17%) and Mississippi (18%) have the lowest. For children under age 5 years, those in D.C. (33%) and Vermont (26%) are the most likely to have received an initial COVID vaccination, while Alabama, Louisiana, and Mississippi share national-low rates of 2%, the AAP said its report, which is based on CDC data.

When all states and territories are combined, 71% of children aged 12-17 have received at least one dose of vaccine, as have 38.6% of all children 5-11 years old and 6.7% of those under age 5. Almost 61% of the nation’s 16- to 17-year-olds have been fully vaccinated, along with 31.5% of those aged 5-11 and 2.4% of children younger than 5 years, the CDC said on its COVID Data Tracker.

About 42 million children – 58% of the population under the age of 18 years – have not received any vaccine yet, the AAP noted. Meanwhile, CDC data indicate that 36 children died of COVID in the last week, with pediatric deaths now totaling 1,781 over the course of the pandemic.

The Food and Drug Administration has approved a whooping cough vaccine that protects newborns under 2 months of age.

The federal agency on Oct. 7 approved Boostrix for use during the last 3 months of pregnancy to prevent pertussis in infants under 2 months old. The vaccine, manufactured by GlaxoSmithKline, was previously approved among pregnant people for their own protection.

“Infants younger than 2 months of age are too young to be protected by the childhood pertussis vaccine series,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release. “This is the first vaccine approved specifically for use during pregnancy to prevent a disease in young infants whose mothers are vaccinated during pregnancy.”

Pertussis is a highly contagious respiratory tract infection caused by the bacterium Bordetella pertussis. Most cases that result in hospitalizations and death are among infants within 2 months of birth.

The FDA said its decision was based on data from observational studies, which included 108 cases of pertussis in infants younger than 2 months old. According to data evaluated by the agency, the vaccine was 78% effective in preventing whooping cough.

Boostrix is administered as a single 0.5-mL dose.

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

The Food and Drug Administration has approved a whooping cough vaccine that protects newborns under 2 months of age.

The federal agency on Oct. 7 approved Boostrix for use during the last 3 months of pregnancy to prevent pertussis in infants under 2 months old. The vaccine, manufactured by GlaxoSmithKline, was previously approved among pregnant people for their own protection.

“Infants younger than 2 months of age are too young to be protected by the childhood pertussis vaccine series,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release. “This is the first vaccine approved specifically for use during pregnancy to prevent a disease in young infants whose mothers are vaccinated during pregnancy.”

Pertussis is a highly contagious respiratory tract infection caused by the bacterium Bordetella pertussis. Most cases that result in hospitalizations and death are among infants within 2 months of birth.

The FDA said its decision was based on data from observational studies, which included 108 cases of pertussis in infants younger than 2 months old. According to data evaluated by the agency, the vaccine was 78% effective in preventing whooping cough.

Boostrix is administered as a single 0.5-mL dose.

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

The Food and Drug Administration has approved a whooping cough vaccine that protects newborns under 2 months of age.

The federal agency on Oct. 7 approved Boostrix for use during the last 3 months of pregnancy to prevent pertussis in infants under 2 months old. The vaccine, manufactured by GlaxoSmithKline, was previously approved among pregnant people for their own protection.

“Infants younger than 2 months of age are too young to be protected by the childhood pertussis vaccine series,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release. “This is the first vaccine approved specifically for use during pregnancy to prevent a disease in young infants whose mothers are vaccinated during pregnancy.”

Pertussis is a highly contagious respiratory tract infection caused by the bacterium Bordetella pertussis. Most cases that result in hospitalizations and death are among infants within 2 months of birth.

The FDA said its decision was based on data from observational studies, which included 108 cases of pertussis in infants younger than 2 months old. According to data evaluated by the agency, the vaccine was 78% effective in preventing whooping cough.

Boostrix is administered as a single 0.5-mL dose.

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

The last full week of September brought a 4th straight week of declines in the number of new COVID-19 cases reported among children, according to the American Academy of Pediatrics and the Children’s Hospital Association.

The new-case total of 39,200 for the week of Sept. 23-29 was down by almost 28% from the previous week, with the month of September bringing a decline of about 57% in reported cases for the 45 states and territories that are still releasing pediatric COVID data on their health department websites, the AAP and CHA said in their joint weekly report.

New cases dropped in all four regions after the Northeast and West had seen increases the previous week, and the distribution of cases for the latest week was fairly even, with the Midwest and Northeast right around 10,000, the South slightly over 10,000, and the West under 10,000 by about the same amount. At the state level, the largest increases – around 1.5% – over the last 2 weeks occurred in Kentucky and Nevada, the AAP/CHA data show.

The cumulative number of COVID-19 cases in children was almost 14.8 million as of Sept. 29, with children representing 18.4% of all cases since the pandemic began, the AAP and CHA said. The Centers for Disease Control and Prevention, which is able to use a uniform age range of 0-17 years, puts total cases at 15.2 million and the proportion of child cases at 17.4%. Total deaths in children from COVID as of Oct. 3 were 1,745, the CDC reported.

New vaccinations, in the meantime, are being added in numbers only slightly higher than new cases. Initial COVID vaccinations for the week of Sept. 22-28 were about 44,000 for children under 5 years of age (down from 51,000 the week before), 24,000 for children aged 5-11 years (down from 28,000), and 17,000 for those aged 12-17 (down from 18,000), the AAP said in its weekly vaccination report.

To look at it another way, the total proportion of children under 5 years of age who had received at least one dose of COVID vaccine as of Sept. 28 was 6.5%, compared with 6.4% on Sept. 21, while the corresponding rates for children aged 5-11 and 12-17 were unchanged at 38.5% and 70.9%. The 12- to 17-year-olds, in fact, have been stuck at 70.9% since Sept. 13, according to data from the CDC.

In a recent study published in Vaccine, investigators attributed the discrepancies between age groups at least partly to the acceptance of misinformation about vaccine safety in general and the COVID-19 vaccines in particular.

“All of the misconceptions we studied focused in one way or another on the safety of vaccination, and that explains why people’s misbeliefs about vaccinating kids are so highly related to their concerns about vaccines in general. Unfortunately, those concerns weigh even more heavily when adults consider vaccinating children,” lead author Dan Romer, PhD, of the University of Pennsylvania, Philadelphia, said in a written statement.

The last full week of September brought a 4th straight week of declines in the number of new COVID-19 cases reported among children, according to the American Academy of Pediatrics and the Children’s Hospital Association.

The new-case total of 39,200 for the week of Sept. 23-29 was down by almost 28% from the previous week, with the month of September bringing a decline of about 57% in reported cases for the 45 states and territories that are still releasing pediatric COVID data on their health department websites, the AAP and CHA said in their joint weekly report.

New cases dropped in all four regions after the Northeast and West had seen increases the previous week, and the distribution of cases for the latest week was fairly even, with the Midwest and Northeast right around 10,000, the South slightly over 10,000, and the West under 10,000 by about the same amount. At the state level, the largest increases – around 1.5% – over the last 2 weeks occurred in Kentucky and Nevada, the AAP/CHA data show.

The cumulative number of COVID-19 cases in children was almost 14.8 million as of Sept. 29, with children representing 18.4% of all cases since the pandemic began, the AAP and CHA said. The Centers for Disease Control and Prevention, which is able to use a uniform age range of 0-17 years, puts total cases at 15.2 million and the proportion of child cases at 17.4%. Total deaths in children from COVID as of Oct. 3 were 1,745, the CDC reported.

New vaccinations, in the meantime, are being added in numbers only slightly higher than new cases. Initial COVID vaccinations for the week of Sept. 22-28 were about 44,000 for children under 5 years of age (down from 51,000 the week before), 24,000 for children aged 5-11 years (down from 28,000), and 17,000 for those aged 12-17 (down from 18,000), the AAP said in its weekly vaccination report.

To look at it another way, the total proportion of children under 5 years of age who had received at least one dose of COVID vaccine as of Sept. 28 was 6.5%, compared with 6.4% on Sept. 21, while the corresponding rates for children aged 5-11 and 12-17 were unchanged at 38.5% and 70.9%. The 12- to 17-year-olds, in fact, have been stuck at 70.9% since Sept. 13, according to data from the CDC.

In a recent study published in Vaccine, investigators attributed the discrepancies between age groups at least partly to the acceptance of misinformation about vaccine safety in general and the COVID-19 vaccines in particular.

“All of the misconceptions we studied focused in one way or another on the safety of vaccination, and that explains why people’s misbeliefs about vaccinating kids are so highly related to their concerns about vaccines in general. Unfortunately, those concerns weigh even more heavily when adults consider vaccinating children,” lead author Dan Romer, PhD, of the University of Pennsylvania, Philadelphia, said in a written statement.

The last full week of September brought a 4th straight week of declines in the number of new COVID-19 cases reported among children, according to the American Academy of Pediatrics and the Children’s Hospital Association.

The new-case total of 39,200 for the week of Sept. 23-29 was down by almost 28% from the previous week, with the month of September bringing a decline of about 57% in reported cases for the 45 states and territories that are still releasing pediatric COVID data on their health department websites, the AAP and CHA said in their joint weekly report.

New cases dropped in all four regions after the Northeast and West had seen increases the previous week, and the distribution of cases for the latest week was fairly even, with the Midwest and Northeast right around 10,000, the South slightly over 10,000, and the West under 10,000 by about the same amount. At the state level, the largest increases – around 1.5% – over the last 2 weeks occurred in Kentucky and Nevada, the AAP/CHA data show.

The cumulative number of COVID-19 cases in children was almost 14.8 million as of Sept. 29, with children representing 18.4% of all cases since the pandemic began, the AAP and CHA said. The Centers for Disease Control and Prevention, which is able to use a uniform age range of 0-17 years, puts total cases at 15.2 million and the proportion of child cases at 17.4%. Total deaths in children from COVID as of Oct. 3 were 1,745, the CDC reported.

New vaccinations, in the meantime, are being added in numbers only slightly higher than new cases. Initial COVID vaccinations for the week of Sept. 22-28 were about 44,000 for children under 5 years of age (down from 51,000 the week before), 24,000 for children aged 5-11 years (down from 28,000), and 17,000 for those aged 12-17 (down from 18,000), the AAP said in its weekly vaccination report.

To look at it another way, the total proportion of children under 5 years of age who had received at least one dose of COVID vaccine as of Sept. 28 was 6.5%, compared with 6.4% on Sept. 21, while the corresponding rates for children aged 5-11 and 12-17 were unchanged at 38.5% and 70.9%. The 12- to 17-year-olds, in fact, have been stuck at 70.9% since Sept. 13, according to data from the CDC.

In a recent study published in Vaccine, investigators attributed the discrepancies between age groups at least partly to the acceptance of misinformation about vaccine safety in general and the COVID-19 vaccines in particular.

“All of the misconceptions we studied focused in one way or another on the safety of vaccination, and that explains why people’s misbeliefs about vaccinating kids are so highly related to their concerns about vaccines in general. Unfortunately, those concerns weigh even more heavily when adults consider vaccinating children,” lead author Dan Romer, PhD, of the University of Pennsylvania, Philadelphia, said in a written statement.

The Food and Drug Administration has approved the HIV-1 medication ibalizumab-uiyk (Trogarzo, Theratechnologies) for administration by intravenous push.

Ibalizumab-uiyk, a long-acting monoclonal antibody, was first approved by the FDA in 2018 for the treatment of adults with multidrug-resistant HIV-1. It is used in combination with other antiretroviral drugs.

Prior to this approval, the drug was administered intravenously as a single 2,000-mg loading dose, followed by an 800-mg maintenance dose every 2 weeks by a trained medical professional. The intravenous infusion is given over 15-30 minutes, according to the Trogarzo website. Now, the maintenance dose can be administered by intravenous push, a method where the undiluted medication is delivered intravenously by injection, in just 30 seconds.

“The evolution of Trogarzo administration from intravenous infusion to intravenous push means less preparation and treatment time in clinics for patients and their health care providers, possibly allowing for more clinics to administer this treatment,” said Christian Marsolais, PhD, the chief medical officer of Theratechnologies, in an Oct. 3 press release.

The FDA approval of the intravenous push method was based on a clinical study which found that ibalizumab administered via intravenous push had similar safety and pharmacokinetic profiles as the intravenous infusion method. So far, 350 individuals have received ibalizumab as a part of the clinical development program, including 19 people who received the medication via intravenous push. The medication is also being studied for administration via intramuscular injection, the press release said.

The most common side effects of ibalizumab include diarrhea, dizziness, nausea, and rash. Severe adverse events have been reported in two patients: one who developed immune reconstitution inflammatory syndrome and another who reported a severe rash.

While multidrug-resistant HIV that would require ibalizumab is not very common – one study found it occurred in fewer than 2% of people with HIV in Western Europe – it is a “very difficult problem because we need to treat these patients to try to achieve virologic suppression,” Monica Gandhi, MD, MPH, associate chief of the division of HIV, infectious diseases, and global medicine at the University of California, San Francisco, noted in an email. While providers generally try to use nonintravenous medications when possible, ibalizumab is an important medication for people with multidrug-resistant HIV and limited treatment options.

“One barrier to administration was the need for IV infusion over 15-30 minutes,” Dr. Gandhi added. “The ability to give this medication as an IV push is an important breakthrough, as we could give this medication more readily for the relatively low number of individuals who will need it.”

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

The Food and Drug Administration has approved the HIV-1 medication ibalizumab-uiyk (Trogarzo, Theratechnologies) for administration by intravenous push.

Ibalizumab-uiyk, a long-acting monoclonal antibody, was first approved by the FDA in 2018 for the treatment of adults with multidrug-resistant HIV-1. It is used in combination with other antiretroviral drugs.

Prior to this approval, the drug was administered intravenously as a single 2,000-mg loading dose, followed by an 800-mg maintenance dose every 2 weeks by a trained medical professional. The intravenous infusion is given over 15-30 minutes, according to the Trogarzo website. Now, the maintenance dose can be administered by intravenous push, a method where the undiluted medication is delivered intravenously by injection, in just 30 seconds.

“The evolution of Trogarzo administration from intravenous infusion to intravenous push means less preparation and treatment time in clinics for patients and their health care providers, possibly allowing for more clinics to administer this treatment,” said Christian Marsolais, PhD, the chief medical officer of Theratechnologies, in an Oct. 3 press release.

The FDA approval of the intravenous push method was based on a clinical study which found that ibalizumab administered via intravenous push had similar safety and pharmacokinetic profiles as the intravenous infusion method. So far, 350 individuals have received ibalizumab as a part of the clinical development program, including 19 people who received the medication via intravenous push. The medication is also being studied for administration via intramuscular injection, the press release said.

The most common side effects of ibalizumab include diarrhea, dizziness, nausea, and rash. Severe adverse events have been reported in two patients: one who developed immune reconstitution inflammatory syndrome and another who reported a severe rash.

While multidrug-resistant HIV that would require ibalizumab is not very common – one study found it occurred in fewer than 2% of people with HIV in Western Europe – it is a “very difficult problem because we need to treat these patients to try to achieve virologic suppression,” Monica Gandhi, MD, MPH, associate chief of the division of HIV, infectious diseases, and global medicine at the University of California, San Francisco, noted in an email. While providers generally try to use nonintravenous medications when possible, ibalizumab is an important medication for people with multidrug-resistant HIV and limited treatment options.

“One barrier to administration was the need for IV infusion over 15-30 minutes,” Dr. Gandhi added. “The ability to give this medication as an IV push is an important breakthrough, as we could give this medication more readily for the relatively low number of individuals who will need it.”

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

The Food and Drug Administration has approved the HIV-1 medication ibalizumab-uiyk (Trogarzo, Theratechnologies) for administration by intravenous push.

Ibalizumab-uiyk, a long-acting monoclonal antibody, was first approved by the FDA in 2018 for the treatment of adults with multidrug-resistant HIV-1. It is used in combination with other antiretroviral drugs.

Prior to this approval, the drug was administered intravenously as a single 2,000-mg loading dose, followed by an 800-mg maintenance dose every 2 weeks by a trained medical professional. The intravenous infusion is given over 15-30 minutes, according to the Trogarzo website. Now, the maintenance dose can be administered by intravenous push, a method where the undiluted medication is delivered intravenously by injection, in just 30 seconds.

“The evolution of Trogarzo administration from intravenous infusion to intravenous push means less preparation and treatment time in clinics for patients and their health care providers, possibly allowing for more clinics to administer this treatment,” said Christian Marsolais, PhD, the chief medical officer of Theratechnologies, in an Oct. 3 press release.

The FDA approval of the intravenous push method was based on a clinical study which found that ibalizumab administered via intravenous push had similar safety and pharmacokinetic profiles as the intravenous infusion method. So far, 350 individuals have received ibalizumab as a part of the clinical development program, including 19 people who received the medication via intravenous push. The medication is also being studied for administration via intramuscular injection, the press release said.

The most common side effects of ibalizumab include diarrhea, dizziness, nausea, and rash. Severe adverse events have been reported in two patients: one who developed immune reconstitution inflammatory syndrome and another who reported a severe rash.

While multidrug-resistant HIV that would require ibalizumab is not very common – one study found it occurred in fewer than 2% of people with HIV in Western Europe – it is a “very difficult problem because we need to treat these patients to try to achieve virologic suppression,” Monica Gandhi, MD, MPH, associate chief of the division of HIV, infectious diseases, and global medicine at the University of California, San Francisco, noted in an email. While providers generally try to use nonintravenous medications when possible, ibalizumab is an important medication for people with multidrug-resistant HIV and limited treatment options.

“One barrier to administration was the need for IV infusion over 15-30 minutes,” Dr. Gandhi added. “The ability to give this medication as an IV push is an important breakthrough, as we could give this medication more readily for the relatively low number of individuals who will need it.”

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

The Food and Drug Administration has granted an accelerated approval for a new drug, futibatinib (Lytgobi), to be used for patients with a certain type of biliary tract cancer. Futibatinib was granted priority review and breakthrough designation, the agency said in its announcement.

Futibatinib is indicated for use in adult patients with previously treated, unresectable, locally advanced, or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements.

The FDA noted that efficacy was evaluated in a multicenter, open-label, single-arm trial (known as TAS-120-101 [NCT02052778]), which involved 103 patients with such tumors. The presence of FGFR2 fusions or other rearrangements was determined using next-generation sequencing.

All the patients in this trial received futibatinib (20 mg orally once daily) until disease progression or unacceptable toxicity.

The overall response rate was 42% (95% confidence interval, 32%-52%), and all of the 43 patients who responded achieved partial responses.

The median duration of response was 9.7 months (95% CI, 7.6-17.1).

The most common adverse reactions that occurred in 20% or more of patients were nail toxicity, musculoskeletal pain, constipation, diarrhea, fatigue, dry mouth, alopecia, stomatitis, abdominal pain, dry skin, arthralgia, dysgeusia, dry eye, nausea, decreased appetite, urinary tract infection, palmar-plantar erythrodysesthesia syndrome, and vomiting.

The manufacturer noted in its announcement that futibatinib covalently binds to FGFR2 and inhibits the signaling pathway. The other approved FGFR inhibitors are reversible ATP-competitive inhibitors.

The company also provided some background information on the cancer.

As a whole, cholangiocarcinoma is an aggressive cancer of the bile ducts. It is diagnosed in approximately 8000 individuals each year in the United States, the company noted.

These cases include both intrahepatic (inside the liver) and extrahepatic (outside the liver) forms of the disease. Approximately 20% of patients diagnosed with cholangiocarcinoma have the intrahepatic form of the disease. Among these 20%, approximately 10%-16% of patients have FGFR2 gene rearrangements, including fusions, which promote tumor proliferation.

Futibatinib is “a key example of the potential of precision medicine in iCCA [intrahepatic cholangiocarcinoma] and represents another advance in the treatment of this rare and challenging disease,” said medical oncologist Lipika Goyal, MD, MPhil, of the Massachusetts General Hospital Cancer Center, Boston, and lead investigator of the pivotal study that supported the approval.

“I am encouraged that treatment options continue to expand and evolve for this disease through the dedicated efforts of many over several years,” she commented in the company’s press release.

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

The Food and Drug Administration has granted an accelerated approval for a new drug, futibatinib (Lytgobi), to be used for patients with a certain type of biliary tract cancer. Futibatinib was granted priority review and breakthrough designation, the agency said in its announcement.

Futibatinib is indicated for use in adult patients with previously treated, unresectable, locally advanced, or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements.

The FDA noted that efficacy was evaluated in a multicenter, open-label, single-arm trial (known as TAS-120-101 [NCT02052778]), which involved 103 patients with such tumors. The presence of FGFR2 fusions or other rearrangements was determined using next-generation sequencing.

All the patients in this trial received futibatinib (20 mg orally once daily) until disease progression or unacceptable toxicity.

The overall response rate was 42% (95% confidence interval, 32%-52%), and all of the 43 patients who responded achieved partial responses.

The median duration of response was 9.7 months (95% CI, 7.6-17.1).

The most common adverse reactions that occurred in 20% or more of patients were nail toxicity, musculoskeletal pain, constipation, diarrhea, fatigue, dry mouth, alopecia, stomatitis, abdominal pain, dry skin, arthralgia, dysgeusia, dry eye, nausea, decreased appetite, urinary tract infection, palmar-plantar erythrodysesthesia syndrome, and vomiting.

The manufacturer noted in its announcement that futibatinib covalently binds to FGFR2 and inhibits the signaling pathway. The other approved FGFR inhibitors are reversible ATP-competitive inhibitors.

The company also provided some background information on the cancer.

As a whole, cholangiocarcinoma is an aggressive cancer of the bile ducts. It is diagnosed in approximately 8000 individuals each year in the United States, the company noted.

These cases include both intrahepatic (inside the liver) and extrahepatic (outside the liver) forms of the disease. Approximately 20% of patients diagnosed with cholangiocarcinoma have the intrahepatic form of the disease. Among these 20%, approximately 10%-16% of patients have FGFR2 gene rearrangements, including fusions, which promote tumor proliferation.

Futibatinib is “a key example of the potential of precision medicine in iCCA [intrahepatic cholangiocarcinoma] and represents another advance in the treatment of this rare and challenging disease,” said medical oncologist Lipika Goyal, MD, MPhil, of the Massachusetts General Hospital Cancer Center, Boston, and lead investigator of the pivotal study that supported the approval.

“I am encouraged that treatment options continue to expand and evolve for this disease through the dedicated efforts of many over several years,” she commented in the company’s press release.

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

The Food and Drug Administration has granted an accelerated approval for a new drug, futibatinib (Lytgobi), to be used for patients with a certain type of biliary tract cancer. Futibatinib was granted priority review and breakthrough designation, the agency said in its announcement.

Futibatinib is indicated for use in adult patients with previously treated, unresectable, locally advanced, or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements.

The FDA noted that efficacy was evaluated in a multicenter, open-label, single-arm trial (known as TAS-120-101 [NCT02052778]), which involved 103 patients with such tumors. The presence of FGFR2 fusions or other rearrangements was determined using next-generation sequencing.

All the patients in this trial received futibatinib (20 mg orally once daily) until disease progression or unacceptable toxicity.

The overall response rate was 42% (95% confidence interval, 32%-52%), and all of the 43 patients who responded achieved partial responses.

The median duration of response was 9.7 months (95% CI, 7.6-17.1).

The most common adverse reactions that occurred in 20% or more of patients were nail toxicity, musculoskeletal pain, constipation, diarrhea, fatigue, dry mouth, alopecia, stomatitis, abdominal pain, dry skin, arthralgia, dysgeusia, dry eye, nausea, decreased appetite, urinary tract infection, palmar-plantar erythrodysesthesia syndrome, and vomiting.

The manufacturer noted in its announcement that futibatinib covalently binds to FGFR2 and inhibits the signaling pathway. The other approved FGFR inhibitors are reversible ATP-competitive inhibitors.

The company also provided some background information on the cancer.

As a whole, cholangiocarcinoma is an aggressive cancer of the bile ducts. It is diagnosed in approximately 8000 individuals each year in the United States, the company noted.

These cases include both intrahepatic (inside the liver) and extrahepatic (outside the liver) forms of the disease. Approximately 20% of patients diagnosed with cholangiocarcinoma have the intrahepatic form of the disease. Among these 20%, approximately 10%-16% of patients have FGFR2 gene rearrangements, including fusions, which promote tumor proliferation.

Futibatinib is “a key example of the potential of precision medicine in iCCA [intrahepatic cholangiocarcinoma] and represents another advance in the treatment of this rare and challenging disease,” said medical oncologist Lipika Goyal, MD, MPhil, of the Massachusetts General Hospital Cancer Center, Boston, and lead investigator of the pivotal study that supported the approval.

“I am encouraged that treatment options continue to expand and evolve for this disease through the dedicated efforts of many over several years,” she commented in the company’s press release.

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

The Food and Drug Administration has approved dupilumab for treating adults with prurigo nodularis, the first treatment approved for this indication, according to a press release from the manufacturers.

Recent studies of dupilumab (Dupixent), which inhibits the signaling of the interleukin-4 and IL-13 pathways, show significant improvements in both itchiness and lesion counts, compared with placebo, in adults with prurigo nodularis (PN).

Approval was based on data from two randomized, controlled trials, PRIME and PRIME2, comparing dupilumab with placebo in 311 adults with uncontrolled PN, according to the release issued by Regeneron and Sanofi. Dupilumab is administered via a 300 mg subcutaneous injection every 2 weeks after a loading dose.

The primary endpoint in PRIME and PRIME 2 was a clinically meaningful improvement in itch from baseline as measured by at least a 4-point reduction in the Worst Itch Numeric Rating Scale, a 0-10 scale, at 24 and 12 weeks, respectively. In the studies, 60% and 58% of patients treated with dupilumab met the primary endpoint at 24 weeks, compared with 18% and 20% of those on placebo. At 24 weeks, 48% and 45% of patients on dupilumab achieved clear or almost clear skin, another study endpoint, compared with 18% and 16% among those on placebo.* 

In PRIME and PRIME2, 44% and 37% of patients on dupilumab met the primary endpoint at 12 weeks versus16% and 22% among those on placebo.

Safety profiles were similar to those seen in other dupilumab studies, according to the release. The most common adverse events in the two studies combined were nasopharyngitis, reported in 5% of those on dupilumab versus 2% of those on placebo; conjunctivitis in 4% versus 1%; herpes infection in 3% versus 0; dizziness in 3% vs. 1%; muscle pain in 3% versus 1%; and diarrhea in 3% versus 1%.

Phase 3 data on dupilumab for PN were recently presented at the annual congress of the European Academy of Dermatology and Venereology.

A regulatory submission for dupilumab for treating PN is in progress at the European Medicines Agency, and submissions are planned to regulatory agencies in additional countries later in 2022, according to the company press release.

Dupilumab is currently approved in the United States for atopic dermatitis in children aged 6 months and older and adults with moderate to severe atopic dermatitis and in children and adults aged 6 years and older with moderate to severe eosinophilic or oral steroid-dependent asthma, as well as for the treatment of chronic rhinosinusitis with nasal polyposis in adults, and for the treatment of eosinophilic esophagitis in adults and children aged 12 years and older, weighing at least 40 kg. Dupilumab is under clinical development for the treatment of chronic spontaneous urticaria and bullous pemphigoid, according to the manufacturers.

The studies were supported by Regeneron and Sanofi.

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

*Correction, 9/30/22: An earlier version of this article misstated results of one endpoint. 

The Food and Drug Administration has approved dupilumab for treating adults with prurigo nodularis, the first treatment approved for this indication, according to a press release from the manufacturers.

Recent studies of dupilumab (Dupixent), which inhibits the signaling of the interleukin-4 and IL-13 pathways, show significant improvements in both itchiness and lesion counts, compared with placebo, in adults with prurigo nodularis (PN).

Approval was based on data from two randomized, controlled trials, PRIME and PRIME2, comparing dupilumab with placebo in 311 adults with uncontrolled PN, according to the release issued by Regeneron and Sanofi. Dupilumab is administered via a 300 mg subcutaneous injection every 2 weeks after a loading dose.

The primary endpoint in PRIME and PRIME 2 was a clinically meaningful improvement in itch from baseline as measured by at least a 4-point reduction in the Worst Itch Numeric Rating Scale, a 0-10 scale, at 24 and 12 weeks, respectively. In the studies, 60% and 58% of patients treated with dupilumab met the primary endpoint at 24 weeks, compared with 18% and 20% of those on placebo. At 24 weeks, 48% and 45% of patients on dupilumab achieved clear or almost clear skin, another study endpoint, compared with 18% and 16% among those on placebo.* 

In PRIME and PRIME2, 44% and 37% of patients on dupilumab met the primary endpoint at 12 weeks versus16% and 22% among those on placebo.

Safety profiles were similar to those seen in other dupilumab studies, according to the release. The most common adverse events in the two studies combined were nasopharyngitis, reported in 5% of those on dupilumab versus 2% of those on placebo; conjunctivitis in 4% versus 1%; herpes infection in 3% versus 0; dizziness in 3% vs. 1%; muscle pain in 3% versus 1%; and diarrhea in 3% versus 1%.

Phase 3 data on dupilumab for PN were recently presented at the annual congress of the European Academy of Dermatology and Venereology.

A regulatory submission for dupilumab for treating PN is in progress at the European Medicines Agency, and submissions are planned to regulatory agencies in additional countries later in 2022, according to the company press release.

Dupilumab is currently approved in the United States for atopic dermatitis in children aged 6 months and older and adults with moderate to severe atopic dermatitis and in children and adults aged 6 years and older with moderate to severe eosinophilic or oral steroid-dependent asthma, as well as for the treatment of chronic rhinosinusitis with nasal polyposis in adults, and for the treatment of eosinophilic esophagitis in adults and children aged 12 years and older, weighing at least 40 kg. Dupilumab is under clinical development for the treatment of chronic spontaneous urticaria and bullous pemphigoid, according to the manufacturers.

The studies were supported by Regeneron and Sanofi.

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

*Correction, 9/30/22: An earlier version of this article misstated results of one endpoint. 

The Food and Drug Administration has approved dupilumab for treating adults with prurigo nodularis, the first treatment approved for this indication, according to a press release from the manufacturers.

Recent studies of dupilumab (Dupixent), which inhibits the signaling of the interleukin-4 and IL-13 pathways, show significant improvements in both itchiness and lesion counts, compared with placebo, in adults with prurigo nodularis (PN).

Approval was based on data from two randomized, controlled trials, PRIME and PRIME2, comparing dupilumab with placebo in 311 adults with uncontrolled PN, according to the release issued by Regeneron and Sanofi. Dupilumab is administered via a 300 mg subcutaneous injection every 2 weeks after a loading dose.

The primary endpoint in PRIME and PRIME 2 was a clinically meaningful improvement in itch from baseline as measured by at least a 4-point reduction in the Worst Itch Numeric Rating Scale, a 0-10 scale, at 24 and 12 weeks, respectively. In the studies, 60% and 58% of patients treated with dupilumab met the primary endpoint at 24 weeks, compared with 18% and 20% of those on placebo. At 24 weeks, 48% and 45% of patients on dupilumab achieved clear or almost clear skin, another study endpoint, compared with 18% and 16% among those on placebo.* 

In PRIME and PRIME2, 44% and 37% of patients on dupilumab met the primary endpoint at 12 weeks versus16% and 22% among those on placebo.

Safety profiles were similar to those seen in other dupilumab studies, according to the release. The most common adverse events in the two studies combined were nasopharyngitis, reported in 5% of those on dupilumab versus 2% of those on placebo; conjunctivitis in 4% versus 1%; herpes infection in 3% versus 0; dizziness in 3% vs. 1%; muscle pain in 3% versus 1%; and diarrhea in 3% versus 1%.

Phase 3 data on dupilumab for PN were recently presented at the annual congress of the European Academy of Dermatology and Venereology.

A regulatory submission for dupilumab for treating PN is in progress at the European Medicines Agency, and submissions are planned to regulatory agencies in additional countries later in 2022, according to the company press release.

Dupilumab is currently approved in the United States for atopic dermatitis in children aged 6 months and older and adults with moderate to severe atopic dermatitis and in children and adults aged 6 years and older with moderate to severe eosinophilic or oral steroid-dependent asthma, as well as for the treatment of chronic rhinosinusitis with nasal polyposis in adults, and for the treatment of eosinophilic esophagitis in adults and children aged 12 years and older, weighing at least 40 kg. Dupilumab is under clinical development for the treatment of chronic spontaneous urticaria and bullous pemphigoid, according to the manufacturers.

The studies were supported by Regeneron and Sanofi.

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

*Correction, 9/30/22: An earlier version of this article misstated results of one endpoint. 

New COVID-19 cases and hospital admissions in children continue to decline, while the slow pace of vaccinations has not deterred manufacturers from seeking new emergency authorizations.

There were just over 55,000 new cases reported during the week of Sept. 16-22, marking three consecutive weeks of declines through the end of summer. Since reaching a post-Omicron peak of 112,000 in late May, the number of weekly cases has fluctuated, with no stretch of increases or decreases lasting more than 4 weeks or the weekly count rising above 97,000 or falling lower than the current 55,000, according to state-level data collected by the American Academy of Pediatrics and the Children’s Hospital Association.

New admissions with confirmed COVID for children aged 0-17 years, which did not follow that pattern and instead continued to rise through the spring and early summer, have been largely decreasing in recent weeks and had fallen to 0.27 per 100,000 population as of Sept. 21 after peaking at 0.46 per 100,000 in late July, the Centers for Disease Control and Prevention reported. A similar decline has been seen for emergency department visits since late August.

The biggest vaccination news of the week came from Moderna and Pfizer and BioNTech, which are each seeking emergency authorization from the Food and Drug Administration for bivalent vaccine boosters that target both the original COVID strain and the BA.4 and BA.5 strains of Omicron.

“Pfizer’s booster would be for children 5 to 11 who have completed a primary vaccination series [and] Moderna’s updated boosters would be for children ages 6 to 17 who have completed a primary vaccination series,” WebMD said.

Although almost 61% of children aged 12-17 years are already fully vaccinated, that is not the case among those aged 5-11, of whom only 31.4% have completed the initial vaccine regimen. Since becoming eligible in June, just 1.9% of children under 5 years of age have been fully vaccinated and 6.3% have received at least one dose, the CDC said on its COVID Data Tracker. The latest data put the already boosted child populations at 28.8% for 12- to 17-year-olds and 14.8% in those aged 5-11.

About 51,000 children under age 5 years received their initial COVID vaccination during the week of Sept. 15-21, and the trend for that measure is one of gradual decline since July. Among the older children that same week, there were 28,000 initial vaccinations in the 5- to 11-year-olds and 18,000 for those aged 12-17, and activity in both age groups has largely stagnated since the spring, according to a separate AAP report based on CDC data.

New COVID-19 cases and hospital admissions in children continue to decline, while the slow pace of vaccinations has not deterred manufacturers from seeking new emergency authorizations.

There were just over 55,000 new cases reported during the week of Sept. 16-22, marking three consecutive weeks of declines through the end of summer. Since reaching a post-Omicron peak of 112,000 in late May, the number of weekly cases has fluctuated, with no stretch of increases or decreases lasting more than 4 weeks or the weekly count rising above 97,000 or falling lower than the current 55,000, according to state-level data collected by the American Academy of Pediatrics and the Children’s Hospital Association.

New admissions with confirmed COVID for children aged 0-17 years, which did not follow that pattern and instead continued to rise through the spring and early summer, have been largely decreasing in recent weeks and had fallen to 0.27 per 100,000 population as of Sept. 21 after peaking at 0.46 per 100,000 in late July, the Centers for Disease Control and Prevention reported. A similar decline has been seen for emergency department visits since late August.

The biggest vaccination news of the week came from Moderna and Pfizer and BioNTech, which are each seeking emergency authorization from the Food and Drug Administration for bivalent vaccine boosters that target both the original COVID strain and the BA.4 and BA.5 strains of Omicron.

“Pfizer’s booster would be for children 5 to 11 who have completed a primary vaccination series [and] Moderna’s updated boosters would be for children ages 6 to 17 who have completed a primary vaccination series,” WebMD said.

Although almost 61% of children aged 12-17 years are already fully vaccinated, that is not the case among those aged 5-11, of whom only 31.4% have completed the initial vaccine regimen. Since becoming eligible in June, just 1.9% of children under 5 years of age have been fully vaccinated and 6.3% have received at least one dose, the CDC said on its COVID Data Tracker. The latest data put the already boosted child populations at 28.8% for 12- to 17-year-olds and 14.8% in those aged 5-11.

About 51,000 children under age 5 years received their initial COVID vaccination during the week of Sept. 15-21, and the trend for that measure is one of gradual decline since July. Among the older children that same week, there were 28,000 initial vaccinations in the 5- to 11-year-olds and 18,000 for those aged 12-17, and activity in both age groups has largely stagnated since the spring, according to a separate AAP report based on CDC data.

New COVID-19 cases and hospital admissions in children continue to decline, while the slow pace of vaccinations has not deterred manufacturers from seeking new emergency authorizations.

There were just over 55,000 new cases reported during the week of Sept. 16-22, marking three consecutive weeks of declines through the end of summer. Since reaching a post-Omicron peak of 112,000 in late May, the number of weekly cases has fluctuated, with no stretch of increases or decreases lasting more than 4 weeks or the weekly count rising above 97,000 or falling lower than the current 55,000, according to state-level data collected by the American Academy of Pediatrics and the Children’s Hospital Association.

New admissions with confirmed COVID for children aged 0-17 years, which did not follow that pattern and instead continued to rise through the spring and early summer, have been largely decreasing in recent weeks and had fallen to 0.27 per 100,000 population as of Sept. 21 after peaking at 0.46 per 100,000 in late July, the Centers for Disease Control and Prevention reported. A similar decline has been seen for emergency department visits since late August.

The biggest vaccination news of the week came from Moderna and Pfizer and BioNTech, which are each seeking emergency authorization from the Food and Drug Administration for bivalent vaccine boosters that target both the original COVID strain and the BA.4 and BA.5 strains of Omicron.

“Pfizer’s booster would be for children 5 to 11 who have completed a primary vaccination series [and] Moderna’s updated boosters would be for children ages 6 to 17 who have completed a primary vaccination series,” WebMD said.

Although almost 61% of children aged 12-17 years are already fully vaccinated, that is not the case among those aged 5-11, of whom only 31.4% have completed the initial vaccine regimen. Since becoming eligible in June, just 1.9% of children under 5 years of age have been fully vaccinated and 6.3% have received at least one dose, the CDC said on its COVID Data Tracker. The latest data put the already boosted child populations at 28.8% for 12- to 17-year-olds and 14.8% in those aged 5-11.

About 51,000 children under age 5 years received their initial COVID vaccination during the week of Sept. 15-21, and the trend for that measure is one of gradual decline since July. Among the older children that same week, there were 28,000 initial vaccinations in the 5- to 11-year-olds and 18,000 for those aged 12-17, and activity in both age groups has largely stagnated since the spring, according to a separate AAP report based on CDC data.