Shots:
- The US FDA has approved the NDA of an oral pellet formulation of Epclusa (sofosbuvir 200 mg/velpatasvir 50 mg and sofosbuvir 150 mg/velpatasvir 37.5 mg) for children aged 3 yrs. who cannot swallow tablets
- The approval is based on a P-II trial evaluating Epclusa in 41 children with HCV for 12 wks. The study showed 83% SVR rate, 88% in HCV genotype 1, 50% in HCV genotype 2, and 100% in HCV genotype 3 & 4, discontinued treatment within one to 20 days of starting treatment who did not achieve cure
- The expanded approval and oral pellet formulation of Epclusa will help children living with HCV, regardless of HCV genotype or liver disease severity
Click here to read full press release/ article | Ref: Business Wire | Image: Reuters
The post Gilead’s Epclusa (Sofosbuvir/Velpatasvir) Receives the US FDA’s Approval for Children with Chronic Hepatitis C Infection first appeared on PharmaShots.
