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 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

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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