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

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

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

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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