User login
Lucas Franki is an associate editor for MDedge News, and has been with the company since 2014. He has a BA in English from Penn State University and is an Eagle Scout.
FDA expands approval of nivolumab for melanoma treatment
The Food and Drug Administration has approved nivolumab for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or in patients with metastatic disease who have undergone complete resection.
Nivolumab was previously approved for the treatment of patients with unresectable or metastatic melanoma, the FDA said in a press statement.
Approval was based on results from the CHECKMATE-238 trial, where 906 patients with completely resected stage IIIB/C or stage IV melanoma received either nivolumab or ipilimumab for up to 1 year. Recurrence-free survival was superior in patients who received nivolumab, with 34% of patients in the nivolumab group experiencing recurrence/death, compared to 45.5% in the ipilimumab group.
The recommended dose and schedule of nivolumab in adjuvant melanoma is 240 mg administered as an IV infusion over 60 minutes every 2 weeks until disease recurrence or unacceptable toxicity, for a maximum of 1 year, according to the FDA.
Nivolumab is marketed as Opdivo by Bristol-Myers Squibb Company.
Find the full press release on the FDA website.
The Food and Drug Administration has approved nivolumab for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or in patients with metastatic disease who have undergone complete resection.
Nivolumab was previously approved for the treatment of patients with unresectable or metastatic melanoma, the FDA said in a press statement.
Approval was based on results from the CHECKMATE-238 trial, where 906 patients with completely resected stage IIIB/C or stage IV melanoma received either nivolumab or ipilimumab for up to 1 year. Recurrence-free survival was superior in patients who received nivolumab, with 34% of patients in the nivolumab group experiencing recurrence/death, compared to 45.5% in the ipilimumab group.
The recommended dose and schedule of nivolumab in adjuvant melanoma is 240 mg administered as an IV infusion over 60 minutes every 2 weeks until disease recurrence or unacceptable toxicity, for a maximum of 1 year, according to the FDA.
Nivolumab is marketed as Opdivo by Bristol-Myers Squibb Company.
Find the full press release on the FDA website.
The Food and Drug Administration has approved nivolumab for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or in patients with metastatic disease who have undergone complete resection.
Nivolumab was previously approved for the treatment of patients with unresectable or metastatic melanoma, the FDA said in a press statement.
Approval was based on results from the CHECKMATE-238 trial, where 906 patients with completely resected stage IIIB/C or stage IV melanoma received either nivolumab or ipilimumab for up to 1 year. Recurrence-free survival was superior in patients who received nivolumab, with 34% of patients in the nivolumab group experiencing recurrence/death, compared to 45.5% in the ipilimumab group.
The recommended dose and schedule of nivolumab in adjuvant melanoma is 240 mg administered as an IV infusion over 60 minutes every 2 weeks until disease recurrence or unacceptable toxicity, for a maximum of 1 year, according to the FDA.
Nivolumab is marketed as Opdivo by Bristol-Myers Squibb Company.
Find the full press release on the FDA website.
FDA approves Eskata for treatment of raised SKs
, according to Aclaris Therapeutics.
Approval for Eskata is based on results from two phase III clinical trials in which patients with raised SKs received either Eskata or a placebo for two doses, one at baseline and one after 2 weeks. Patients who received Eskata were more likely to have their SKs clear completely, compared with the placebo group.
Eskata is approved only for use in the office of a health care provider and is not for home usage.
The most common adverse events associated with Eskata are itching, stinging, crusting, swelling, redness, and scaling at the application site. Serious skin reactions are possible, and if the medication accidentally enters a patient’s eyes, the patient should flush his or her eyes with water for 15-30 minutes.
“This achievement delivers on Aclaris’ commitment to bringing innovative therapies to market that address significant unmet needs in dermatology. For the first time, with the approval of Eskata, patients will have access to an FDA-approved topical, non-invasive treatment for raised SKs,” Dr. Neal Walker, president and chief executive officer of Aclaris, said in written statement.
, according to Aclaris Therapeutics.
Approval for Eskata is based on results from two phase III clinical trials in which patients with raised SKs received either Eskata or a placebo for two doses, one at baseline and one after 2 weeks. Patients who received Eskata were more likely to have their SKs clear completely, compared with the placebo group.
Eskata is approved only for use in the office of a health care provider and is not for home usage.
The most common adverse events associated with Eskata are itching, stinging, crusting, swelling, redness, and scaling at the application site. Serious skin reactions are possible, and if the medication accidentally enters a patient’s eyes, the patient should flush his or her eyes with water for 15-30 minutes.
“This achievement delivers on Aclaris’ commitment to bringing innovative therapies to market that address significant unmet needs in dermatology. For the first time, with the approval of Eskata, patients will have access to an FDA-approved topical, non-invasive treatment for raised SKs,” Dr. Neal Walker, president and chief executive officer of Aclaris, said in written statement.
, according to Aclaris Therapeutics.
Approval for Eskata is based on results from two phase III clinical trials in which patients with raised SKs received either Eskata or a placebo for two doses, one at baseline and one after 2 weeks. Patients who received Eskata were more likely to have their SKs clear completely, compared with the placebo group.
Eskata is approved only for use in the office of a health care provider and is not for home usage.
The most common adverse events associated with Eskata are itching, stinging, crusting, swelling, redness, and scaling at the application site. Serious skin reactions are possible, and if the medication accidentally enters a patient’s eyes, the patient should flush his or her eyes with water for 15-30 minutes.
“This achievement delivers on Aclaris’ commitment to bringing innovative therapies to market that address significant unmet needs in dermatology. For the first time, with the approval of Eskata, patients will have access to an FDA-approved topical, non-invasive treatment for raised SKs,” Dr. Neal Walker, president and chief executive officer of Aclaris, said in written statement.
FDA approves infliximab biosimilar Ixifi for all of Remicade’s indications
The Food and Drug Administration has approved Ixifi (infliximab-qbtx), a biosimilar of Remicade, the original infliximab product. Ixifi is the third infliximab biosimilar to be approved by the FDA, and it is approved for all the same indications as Remicade, according to an announcement from its manufacturer, Pfizer.
Ixifi and Remicade are approved for the treatment of rheumatoid arthritis in combination with methotrexate, Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.
The most common adverse events associated with Ixifi are upper respiratory infections, sinusitis, pharyngitis, infusion-related reactions, headache, and abdominal pain.
The Food and Drug Administration has approved Ixifi (infliximab-qbtx), a biosimilar of Remicade, the original infliximab product. Ixifi is the third infliximab biosimilar to be approved by the FDA, and it is approved for all the same indications as Remicade, according to an announcement from its manufacturer, Pfizer.
Ixifi and Remicade are approved for the treatment of rheumatoid arthritis in combination with methotrexate, Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.
The most common adverse events associated with Ixifi are upper respiratory infections, sinusitis, pharyngitis, infusion-related reactions, headache, and abdominal pain.
The Food and Drug Administration has approved Ixifi (infliximab-qbtx), a biosimilar of Remicade, the original infliximab product. Ixifi is the third infliximab biosimilar to be approved by the FDA, and it is approved for all the same indications as Remicade, according to an announcement from its manufacturer, Pfizer.
Ixifi and Remicade are approved for the treatment of rheumatoid arthritis in combination with methotrexate, Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.
The most common adverse events associated with Ixifi are upper respiratory infections, sinusitis, pharyngitis, infusion-related reactions, headache, and abdominal pain.
Clinical trial: The Role of the Robotic Platform in Inguinal Hernia Repair Surgery
The Role of the Robotic Platform in Inguinal Hernia Repair Surgery is an interventional trial currently recruiting patients who require inguinal hernia repair surgery.
The trial will compare postoperative pain in patients undergoing laparoscopic inguinal hernia surgery repair or robotic inguinal hernia repair surgery. The laparoscopic approach has been used frequently and has several advantages. However, it has several disadvantages that the robotic approach may address. As such, the study investigators have hypothesized that the robotic approach will result in less postoperative pain than the laparoscopic approach.
The primary outcome measure is the difference in postoperative pain between patients who undergo robotic inguinal hernia repair and those who undergo laparoscopic inguinal hernia repair during the 2 years following surgery. Secondary outcome measures include differences in surgeon ergonomics between the two approaches, institution cost analysis, and long-term recurrence rate differences, all within 2 years of surgery.
The study will end in May 2019. About 100 people are expected to be included in the final analysis.
Find more information on the study page at Clinicaltrials.gov.
SOURCE: Clinicaltrials.gov. NCT02816658.
The Role of the Robotic Platform in Inguinal Hernia Repair Surgery is an interventional trial currently recruiting patients who require inguinal hernia repair surgery.
The trial will compare postoperative pain in patients undergoing laparoscopic inguinal hernia surgery repair or robotic inguinal hernia repair surgery. The laparoscopic approach has been used frequently and has several advantages. However, it has several disadvantages that the robotic approach may address. As such, the study investigators have hypothesized that the robotic approach will result in less postoperative pain than the laparoscopic approach.
The primary outcome measure is the difference in postoperative pain between patients who undergo robotic inguinal hernia repair and those who undergo laparoscopic inguinal hernia repair during the 2 years following surgery. Secondary outcome measures include differences in surgeon ergonomics between the two approaches, institution cost analysis, and long-term recurrence rate differences, all within 2 years of surgery.
The study will end in May 2019. About 100 people are expected to be included in the final analysis.
Find more information on the study page at Clinicaltrials.gov.
SOURCE: Clinicaltrials.gov. NCT02816658.
The Role of the Robotic Platform in Inguinal Hernia Repair Surgery is an interventional trial currently recruiting patients who require inguinal hernia repair surgery.
The trial will compare postoperative pain in patients undergoing laparoscopic inguinal hernia surgery repair or robotic inguinal hernia repair surgery. The laparoscopic approach has been used frequently and has several advantages. However, it has several disadvantages that the robotic approach may address. As such, the study investigators have hypothesized that the robotic approach will result in less postoperative pain than the laparoscopic approach.
The primary outcome measure is the difference in postoperative pain between patients who undergo robotic inguinal hernia repair and those who undergo laparoscopic inguinal hernia repair during the 2 years following surgery. Secondary outcome measures include differences in surgeon ergonomics between the two approaches, institution cost analysis, and long-term recurrence rate differences, all within 2 years of surgery.
The study will end in May 2019. About 100 people are expected to be included in the final analysis.
Find more information on the study page at Clinicaltrials.gov.
SOURCE: Clinicaltrials.gov. NCT02816658.
FROM CLINICALTRIALS.GOV
PBC disease progression no worse for patients with concomitant NAFLD
, according to Gerald Yosel Minuk, MD, and his associates.
At baseline, the 168 patients in the PBC-only group had higher serum alkaline phosphatase and gamma-glutamyl transferase values than the 68 patients in the NAFLD/PBC group, as well as having higher FIB-4 scores. The percentage of patients with aspartate aminotransferase/platelet ratio indexes (APRI) greater than 1.5 was slightly higher in the PBC-only group, but the difference was not significant.
After follow-up periods averaging 6.7 years in the PBC-only group and 6.4 years in the NAFLD/PBC group, yearly increases in FIB-4 and prevalence of APRI greater than 1.5 were greater in the PBC-only group, though the difference did not reach significance. PBC-only patients were more likely to have developed radiologic evidence of cirrhosis during the follow-up period (42% vs. 19%, P less than .001).
“Were the results of the present study to be confirmed by others, the question arises as to why NAFLD does not adversely and may favorably impact on PBC. Here, it is tempting to speculate that because PBC livers are associated with a paucity of immunosuppressive regulator T cells (Tregs) whereas in NAFLD, Tregs are recruited to the liver in increased numbers, a restoration of the immune balance in PBC livers might explain these findings,” the investigators noted.
Find the full study in Liver International (doi: 10.1111/liv.13644).
, according to Gerald Yosel Minuk, MD, and his associates.
At baseline, the 168 patients in the PBC-only group had higher serum alkaline phosphatase and gamma-glutamyl transferase values than the 68 patients in the NAFLD/PBC group, as well as having higher FIB-4 scores. The percentage of patients with aspartate aminotransferase/platelet ratio indexes (APRI) greater than 1.5 was slightly higher in the PBC-only group, but the difference was not significant.
After follow-up periods averaging 6.7 years in the PBC-only group and 6.4 years in the NAFLD/PBC group, yearly increases in FIB-4 and prevalence of APRI greater than 1.5 were greater in the PBC-only group, though the difference did not reach significance. PBC-only patients were more likely to have developed radiologic evidence of cirrhosis during the follow-up period (42% vs. 19%, P less than .001).
“Were the results of the present study to be confirmed by others, the question arises as to why NAFLD does not adversely and may favorably impact on PBC. Here, it is tempting to speculate that because PBC livers are associated with a paucity of immunosuppressive regulator T cells (Tregs) whereas in NAFLD, Tregs are recruited to the liver in increased numbers, a restoration of the immune balance in PBC livers might explain these findings,” the investigators noted.
Find the full study in Liver International (doi: 10.1111/liv.13644).
, according to Gerald Yosel Minuk, MD, and his associates.
At baseline, the 168 patients in the PBC-only group had higher serum alkaline phosphatase and gamma-glutamyl transferase values than the 68 patients in the NAFLD/PBC group, as well as having higher FIB-4 scores. The percentage of patients with aspartate aminotransferase/platelet ratio indexes (APRI) greater than 1.5 was slightly higher in the PBC-only group, but the difference was not significant.
After follow-up periods averaging 6.7 years in the PBC-only group and 6.4 years in the NAFLD/PBC group, yearly increases in FIB-4 and prevalence of APRI greater than 1.5 were greater in the PBC-only group, though the difference did not reach significance. PBC-only patients were more likely to have developed radiologic evidence of cirrhosis during the follow-up period (42% vs. 19%, P less than .001).
“Were the results of the present study to be confirmed by others, the question arises as to why NAFLD does not adversely and may favorably impact on PBC. Here, it is tempting to speculate that because PBC livers are associated with a paucity of immunosuppressive regulator T cells (Tregs) whereas in NAFLD, Tregs are recruited to the liver in increased numbers, a restoration of the immune balance in PBC livers might explain these findings,” the investigators noted.
Find the full study in Liver International (doi: 10.1111/liv.13644).
FROM LIVER INTERNATIONAL
FDA: Puerto Rico’s medical supply shortage issues continue
“In addition to our ongoing concerns related to IV saline products, we also are particularly focused on the shortage of amino acids for injection,” FDA Commissioner Scott Gottlieb, MD, said in a statement.
The shortage of amino acids for injection predates Hurricane Maria, but the hurricane’s impact worsened the situation by disrupting Baxter’s ability to manufacture amino acids in Puerto Rico. The FDA has worked with Baxter to temporarily import pediatric and adult amino acid injections from the United Kingdom and Italy, as well as working with other amino acid manufacturers to increase supplies.
“We continue to work closely with federal and Puerto Rican authorities to address the needs of manufacturers on the island for power and other resources. These efforts have been focused on the needs of patients – to prevent potential shortages of medically important products where possible, and help ensure that any shortages that do occur are mitigated as quickly as possible,” Dr. Gottlieb said.
Read the full statement on the FDA website.
“In addition to our ongoing concerns related to IV saline products, we also are particularly focused on the shortage of amino acids for injection,” FDA Commissioner Scott Gottlieb, MD, said in a statement.
The shortage of amino acids for injection predates Hurricane Maria, but the hurricane’s impact worsened the situation by disrupting Baxter’s ability to manufacture amino acids in Puerto Rico. The FDA has worked with Baxter to temporarily import pediatric and adult amino acid injections from the United Kingdom and Italy, as well as working with other amino acid manufacturers to increase supplies.
“We continue to work closely with federal and Puerto Rican authorities to address the needs of manufacturers on the island for power and other resources. These efforts have been focused on the needs of patients – to prevent potential shortages of medically important products where possible, and help ensure that any shortages that do occur are mitigated as quickly as possible,” Dr. Gottlieb said.
Read the full statement on the FDA website.
“In addition to our ongoing concerns related to IV saline products, we also are particularly focused on the shortage of amino acids for injection,” FDA Commissioner Scott Gottlieb, MD, said in a statement.
The shortage of amino acids for injection predates Hurricane Maria, but the hurricane’s impact worsened the situation by disrupting Baxter’s ability to manufacture amino acids in Puerto Rico. The FDA has worked with Baxter to temporarily import pediatric and adult amino acid injections from the United Kingdom and Italy, as well as working with other amino acid manufacturers to increase supplies.
“We continue to work closely with federal and Puerto Rican authorities to address the needs of manufacturers on the island for power and other resources. These efforts have been focused on the needs of patients – to prevent potential shortages of medically important products where possible, and help ensure that any shortages that do occur are mitigated as quickly as possible,” Dr. Gottlieb said.
Read the full statement on the FDA website.
FDA: Febuxostat may have increased heart-related death risk
The urate-lowering therapy febuxostat may have a higher risk of heart-related death than does another urate-lowering drug, allopurinol, according to a Safety Alert from the Food and Drug Administration.
The safety trial was commissioned after febuxostat was approved by the FDA in 2009. Clinical trials conducted pre-approval showed an increased risk of heart-related problems, compared with allopurinol, and the drug label already carries a warning about cardiovascular events.
“Once the final results from the manufacturer are received, the FDA will conduct a comprehensive review and will update the public with any new information,” the agency said in the Safety Alert.
[email protected]
The urate-lowering therapy febuxostat may have a higher risk of heart-related death than does another urate-lowering drug, allopurinol, according to a Safety Alert from the Food and Drug Administration.
The safety trial was commissioned after febuxostat was approved by the FDA in 2009. Clinical trials conducted pre-approval showed an increased risk of heart-related problems, compared with allopurinol, and the drug label already carries a warning about cardiovascular events.
“Once the final results from the manufacturer are received, the FDA will conduct a comprehensive review and will update the public with any new information,” the agency said in the Safety Alert.
[email protected]
The urate-lowering therapy febuxostat may have a higher risk of heart-related death than does another urate-lowering drug, allopurinol, according to a Safety Alert from the Food and Drug Administration.
The safety trial was commissioned after febuxostat was approved by the FDA in 2009. Clinical trials conducted pre-approval showed an increased risk of heart-related problems, compared with allopurinol, and the drug label already carries a warning about cardiovascular events.
“Once the final results from the manufacturer are received, the FDA will conduct a comprehensive review and will update the public with any new information,” the agency said in the Safety Alert.
[email protected]
FDA approves obinutuzumab for follicular lymphoma
The Food and Drug Administration has approved obinutuzumab in combination with chemotherapy, followed by obinutuzumab alone in those who responded, for people with previously untreated advanced follicular lymphoma (stage II bulky, III or IV).
The most common adverse events associated with obinutuzumab were infusion reactions, low white blood cell count, upper respiratory tract infection, cough, constipation, and diarrhea. The most common significant adverse events are low white blood cell count, low white blood cell count with fever, and low platelet count.
Obinutuzumab is marketed as Gazyva by Genentech.
“Today’s Gazyva approval is an important advance for the thousands of people diagnosed each year with follicular lymphoma who hope to delay disease progression for as long as possible,” said Sarah Horning, MD, chief medical officer and head of global product development at Genentech, in the company press release.
The Food and Drug Administration has approved obinutuzumab in combination with chemotherapy, followed by obinutuzumab alone in those who responded, for people with previously untreated advanced follicular lymphoma (stage II bulky, III or IV).
The most common adverse events associated with obinutuzumab were infusion reactions, low white blood cell count, upper respiratory tract infection, cough, constipation, and diarrhea. The most common significant adverse events are low white blood cell count, low white blood cell count with fever, and low platelet count.
Obinutuzumab is marketed as Gazyva by Genentech.
“Today’s Gazyva approval is an important advance for the thousands of people diagnosed each year with follicular lymphoma who hope to delay disease progression for as long as possible,” said Sarah Horning, MD, chief medical officer and head of global product development at Genentech, in the company press release.
The Food and Drug Administration has approved obinutuzumab in combination with chemotherapy, followed by obinutuzumab alone in those who responded, for people with previously untreated advanced follicular lymphoma (stage II bulky, III or IV).
The most common adverse events associated with obinutuzumab were infusion reactions, low white blood cell count, upper respiratory tract infection, cough, constipation, and diarrhea. The most common significant adverse events are low white blood cell count, low white blood cell count with fever, and low platelet count.
Obinutuzumab is marketed as Gazyva by Genentech.
“Today’s Gazyva approval is an important advance for the thousands of people diagnosed each year with follicular lymphoma who hope to delay disease progression for as long as possible,” said Sarah Horning, MD, chief medical officer and head of global product development at Genentech, in the company press release.
Infliximab useful in a case of concurrent RA/PBC
The anti–tumor necrosis factor alpha agent infliximab is a beneficial option in the treatment of concurrent rheumatoid arthritis (RA) and primary biliary cholangitis (PBC), according to A.K. Ben, MD, and associates.
In a case report, a 56-year-old woman presented with 5 years of evolving symmetrical polyarthritis involving her large and small joints, and was diagnosed with RA. Methotrexate was initially used as treatment, but after 6 months of continued high disease activity, infliximab was added to treatment. The patient showed good clinical response to the combination treatment.
The combination treatment was stopped after the patient showed abnormal liver function. Antimitochondrial antibody testing was positive, and after a liver biopsy to confirm, the patient was diagnosed with PBC. Ursodeoxycholic acid was prescribed and liver function was normalized.
The patient was restarted on methotrexate and 3 mg/kg infliximab when the RA flared after 6 months and was persistent until the dosage of infliximab was increased to 5 mg/kg. This was effective in the patient, who has experienced disease decline for 5 years.
“Additional studies may be considered to better explore the therapeutic role (dosage and molecule disparities) of TNF [tumor necrosis factor] blockers on clinical and morphological course of PBC associated with RA,” the investigators concluded.
Find the full case report in Internal Medicine: Open Access (doi: 10.4172/2165-8048.1000250).
The anti–tumor necrosis factor alpha agent infliximab is a beneficial option in the treatment of concurrent rheumatoid arthritis (RA) and primary biliary cholangitis (PBC), according to A.K. Ben, MD, and associates.
In a case report, a 56-year-old woman presented with 5 years of evolving symmetrical polyarthritis involving her large and small joints, and was diagnosed with RA. Methotrexate was initially used as treatment, but after 6 months of continued high disease activity, infliximab was added to treatment. The patient showed good clinical response to the combination treatment.
The combination treatment was stopped after the patient showed abnormal liver function. Antimitochondrial antibody testing was positive, and after a liver biopsy to confirm, the patient was diagnosed with PBC. Ursodeoxycholic acid was prescribed and liver function was normalized.
The patient was restarted on methotrexate and 3 mg/kg infliximab when the RA flared after 6 months and was persistent until the dosage of infliximab was increased to 5 mg/kg. This was effective in the patient, who has experienced disease decline for 5 years.
“Additional studies may be considered to better explore the therapeutic role (dosage and molecule disparities) of TNF [tumor necrosis factor] blockers on clinical and morphological course of PBC associated with RA,” the investigators concluded.
Find the full case report in Internal Medicine: Open Access (doi: 10.4172/2165-8048.1000250).
The anti–tumor necrosis factor alpha agent infliximab is a beneficial option in the treatment of concurrent rheumatoid arthritis (RA) and primary biliary cholangitis (PBC), according to A.K. Ben, MD, and associates.
In a case report, a 56-year-old woman presented with 5 years of evolving symmetrical polyarthritis involving her large and small joints, and was diagnosed with RA. Methotrexate was initially used as treatment, but after 6 months of continued high disease activity, infliximab was added to treatment. The patient showed good clinical response to the combination treatment.
The combination treatment was stopped after the patient showed abnormal liver function. Antimitochondrial antibody testing was positive, and after a liver biopsy to confirm, the patient was diagnosed with PBC. Ursodeoxycholic acid was prescribed and liver function was normalized.
The patient was restarted on methotrexate and 3 mg/kg infliximab when the RA flared after 6 months and was persistent until the dosage of infliximab was increased to 5 mg/kg. This was effective in the patient, who has experienced disease decline for 5 years.
“Additional studies may be considered to better explore the therapeutic role (dosage and molecule disparities) of TNF [tumor necrosis factor] blockers on clinical and morphological course of PBC associated with RA,” the investigators concluded.
Find the full case report in Internal Medicine: Open Access (doi: 10.4172/2165-8048.1000250).
FROM INTERNAL MEDICINE: OPEN ACCESS
FDA approves Vimpat for POS treatment in children with epilepsy
The Food and Drug Administration has approved lacosamide for the treatment of partial-onset seizures in children with epilepsy, according to a statement by UCB, manufacturer of the drug.
The approval by the FDA is an extension of the drug’s previous indication, which was approved in 2009 for use in adults, and is based on four clinical trials and pharmacokinetic analyses from adult and pediatric data. The expanded indication is for children older than 4 years, and applies only to the oral tablet. Lacosamide (Vimpat) injections remain indicated only for adult patients older than 17 years.
“Until recently there were few effective treatment options approved for childhood epilepsy. This has contributed to poor seizure control for many, which can be detrimental to overall quality of life. The availability of lacosamide for children with epilepsy has the potential to change the lives of children and their families by providing an additional choice to support them in their epilepsy journey,” Raman Sankar, MD, PhD, professor of neurology and pediatrics and chief of pediatric neurology at the University of California, Los Angeles, said in the statement.
Find the full press release on the UCB website.
The Food and Drug Administration has approved lacosamide for the treatment of partial-onset seizures in children with epilepsy, according to a statement by UCB, manufacturer of the drug.
The approval by the FDA is an extension of the drug’s previous indication, which was approved in 2009 for use in adults, and is based on four clinical trials and pharmacokinetic analyses from adult and pediatric data. The expanded indication is for children older than 4 years, and applies only to the oral tablet. Lacosamide (Vimpat) injections remain indicated only for adult patients older than 17 years.
“Until recently there were few effective treatment options approved for childhood epilepsy. This has contributed to poor seizure control for many, which can be detrimental to overall quality of life. The availability of lacosamide for children with epilepsy has the potential to change the lives of children and their families by providing an additional choice to support them in their epilepsy journey,” Raman Sankar, MD, PhD, professor of neurology and pediatrics and chief of pediatric neurology at the University of California, Los Angeles, said in the statement.
Find the full press release on the UCB website.
The Food and Drug Administration has approved lacosamide for the treatment of partial-onset seizures in children with epilepsy, according to a statement by UCB, manufacturer of the drug.
The approval by the FDA is an extension of the drug’s previous indication, which was approved in 2009 for use in adults, and is based on four clinical trials and pharmacokinetic analyses from adult and pediatric data. The expanded indication is for children older than 4 years, and applies only to the oral tablet. Lacosamide (Vimpat) injections remain indicated only for adult patients older than 17 years.
“Until recently there were few effective treatment options approved for childhood epilepsy. This has contributed to poor seizure control for many, which can be detrimental to overall quality of life. The availability of lacosamide for children with epilepsy has the potential to change the lives of children and their families by providing an additional choice to support them in their epilepsy journey,” Raman Sankar, MD, PhD, professor of neurology and pediatrics and chief of pediatric neurology at the University of California, Los Angeles, said in the statement.
Find the full press release on the UCB website.