FDA OKs expanded use of Gilead’s Epclusa

The FDA approves the use of Gilead Sciences’ (GILD +0.1%) Epclusa (sofosbuvir 400mg/velpatasvir 100mg; sofosbuvir 200mg/velpatasvir 50 mg) for the treatment of patients with chronic hepatitis C infection (HCV) as young as 6 years of age or weighing at least 17 kg, regardless of HCV genotype or liver disease severity.

Its application in Europe is under EMA review.

The agency approved the combo pill in June 2016 for HCV-positive adults with or without cirrhosis and in combination with ribavirin for patients with decompensated cirrhosis.

https://seekingalpha.com/news/3553484-fda-oks-expanded-use-of-gileads-epclusa