FDA News

FDA approves Epclusa for pediatric HCV

Epclusa is now available for the treatment of children with any of the six genotypes of hepatitis C virus after obtaining approval from the FDA, according to a press release.

Previously approved to treat HCV in adults, Epclusa (sofosbuvir/velpatasvir, Gilead Sciences) is indicated in pediatric patients aged 6 years and older or weighing at least 37 pounds.

“This approval will provide additional treatment options for children and adolescents with HCV,” Debra Birnkrant, MD, director of the division of antivirals in the FDA’s Center for Drug Evaluation and Research, said in the release. “This approval will also be important in settings where there is limited ability for health care professionals to conduct HCV genotype testing.”

Epclusa was evaluated in an open-label study of 173 pediatric patients with and without mild cirrhosis. Investigators found no difference between the pharmacokinetics seen in children and those found in adults. Additionally, among 102 patients between ages 12 and 17 years, 93% of patients with genotype 1 and 100% of patients with genotypes 2, 3, 4 and 6 had no detectable virus in the blood 12 weeks after finishing treatment.

For 71 patients between ages 6 and 11 years with HCV genotypes 1, 2, 3 and 4, 93% with genotype 1, 91% with genotype 3 and 100% with genotypes 2 and genotype 4 had no virus detected in the blood 12 weeks after finishing treatment.

“Gilead’s continued commitment to HCV elimination includes bringing our medicines to the most difficult-to-cure populations and today’s decision by the FDA represents an important step toward that goal,” Merdad Parsey, MD, PhD, chief medical officer at Gilead Sciences, said in a company press release. “With consistently high cure rates in clinical trials and in the real world, Epclusa has the potential to help many of the children living with HCV in the United States.”

Reference:

FDA.gov

Gilead.com

Epclusa is now available for the treatment of children with any of the six genotypes of hepatitis C virus after obtaining approval from the FDA, according to a press release.

Previously approved to treat HCV in adults, Epclusa (sofosbuvir/velpatasvir, Gilead Sciences) is indicated in pediatric patients aged 6 years and older or weighing at least 37 pounds.

“This approval will provide additional treatment options for children and adolescents with HCV,” Debra Birnkrant, MD, director of the division of antivirals in the FDA’s Center for Drug Evaluation and Research, said in the release. “This approval will also be important in settings where there is limited ability for health care professionals to conduct HCV genotype testing.”

Epclusa was evaluated in an open-label study of 173 pediatric patients with and without mild cirrhosis. Investigators found no difference between the pharmacokinetics seen in children and those found in adults. Additionally, among 102 patients between ages 12 and 17 years, 93% of patients with genotype 1 and 100% of patients with genotypes 2, 3, 4 and 6 had no detectable virus in the blood 12 weeks after finishing treatment.

For 71 patients between ages 6 and 11 years with HCV genotypes 1, 2, 3 and 4, 93% with genotype 1, 91% with genotype 3 and 100% with genotypes 2 and genotype 4 had no virus detected in the blood 12 weeks after finishing treatment.

“Gilead’s continued commitment to HCV elimination includes bringing our medicines to the most difficult-to-cure populations and today’s decision by the FDA represents an important step toward that goal,” Merdad Parsey, MD, PhD, chief medical officer at Gilead Sciences, said in a company press release. “With consistently high cure rates in clinical trials and in the real world, Epclusa has the potential to help many of the children living with HCV in the United States.”

Reference:

FDA.gov

Gilead.com