Gilead’s Epclusa (Sofosbuvir/Velpatasvir) Receives the US FDA’s Approval for Children with Chronic Hepatitis C Infection

Shots:

• The US FDA has approved sNDA for Epclusa (sofosbuvir 400mg/velpatasvir 100mg; sofosbuvir 200mg/velpatasvir 50 mg) to treat patients with HCV as young as 6 years of age or weighing at least 17 kg, regardless of HCV genotype or liver disease severity
• The approval is based on P-II Study 1143 assessing Epclusa in 175 patients for 12wks. The study showed SVR rate (93% in patients with genotype 1 HCV infection & 100% with genotype 2,3,4 & 6 HCV infection in children aged 12 to <18 yrs.) and a SVR rate (93% in genotype 1 HCV infection, 91 % in genotype 3 HCV infection, and 100% in genotype 2 & 4 HCV infection)
• The expanded approval of Epclusa will help eligible children living with HCV to combat life-threatening and debilitating disease and the therapy has received the FDA & EMA’s approval for treating adults in 2016

Click here ­to­ read full press release/ article | Ref: Gilead | Image: Biospace