EMA to review Gilead's HCV combo

Gilead Sciences Inc. (NASDAQ:GILD) said EMA accepted for accelerated assessment an MAA for a fixed-dose combination of Sovaldi sofosbuvir and ledipasvir ( GS-5885) to treat chronic HCV genotype 1 infection. An accelerated assessment shortens the review period to 150 days from 210. Last month, EMA's CHMP recommended compassionate use of the combination to treat chronic HCV genotype 1 infection in patients who are at high risk of liver decompensation or death. Also last month, Gilead submitted an NDA to FDA for the combination.

The European Commission approved Sovaldi, a nucleotide analog HCV NS5B polymerase inhibitor, in January. Ledipasvir is an HCV NS5A protein inhibitor. ...