EU recommends change to marketing authorisation for Epclusa in chronic hepatitis C virus infection.- Gilead Sciences

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Epclusa (sofosbuvir + velpatasvir), from gilead Sciences in chronic hepatitis C virus (HCV) infection.

The CHMP adopted an extension to the indication for Epclusa as follows: Epclusa is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults patients aged 6 years and older and weighing at least 17 kg. The CHMP also recommended the addition of a new 200/50 mg strength for the film-coated tablets.