European CHMP Adopts Positive Opinion For Gilead's Epclusa - Quick Facts

(RTTNews) - Gilead Sciences Inc. (GILD) announced that the Committee for Medicinal Products for Human Use or CHMP, the scientific committee of the European Medicines Agency or EMA, has adopted a positive opinion on the company's Marketing Authorization Application or MAA for Epclusa, an investigational, pan-genotypic, once-daily tablet containing the nucleotide analogue polymerase inhibitor sofosbuvir or SOF 400 mg and velpatasvir or VEL 100 mg, an investigational pan-genotypic NS5A inhibitor, for the treatment of chronic hepatitis C virus or HCV infection.

The data included in the application support the use of Epclusa (SOF/VEL) in adults with all genotypes (GT1-6) of HCV infection.

The CHMP positive opinion was adopted following an accelerated review procedure, reserved for medicinal products expected to be of major public health interest. The recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for use in the 28 countries of the European Union, Norway and Iceland.