FDA greenlights Gilead’s Epclusa in hepatitis C patients over six years old
Gilead’s Epclusa (sofosbuvir and velpatasvir) has been awarded new marketing approval from the FDA in the treatment of hepatitis C virus (HCV) in children and adult patients, it has been revealed.
The decision is relevant to patients of at least six years of age or those who weigh at least 37 pounds, have any of the six strains of HCV, and have either mild or no cirrhosis. Epclusa adds the approval to its belt alongside an existing FDA approval for HCV in adult patients.
In data drawn from 102 patients between the ages of 12 and 17, 93% of those with HCV strain 1 and 100% of those with strains 2, 3, 4 and 6 were found to have no detectable levels of the virus after taking Epclusa for 12 weeks. Additional data showed that 93% of 71 patients with strains 1, 2, 3 or 4 also had no detectable levels of the virus, as did 91% of patients with strain 3 and 100% of patients with strains 2 and 4.
The US regulator noted that the safety and efficacy profile of the drug had not been established in patients younger than six years of age.
“This approval will provide additional treatment options for children and adolescents with HCV,” said Dr Debra Birnkrant, Director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research. “This approval will also be important in settings where there is limited ability for health care professionals to conduct HCV genotype testing.”
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