BioCentury
ARTICLE | Company News

CHMP backs compassionate use of sofosbuvir/ledipasvir

February 22, 2014 1:46 AM UTC

EMA's CHMP recommended compassionate use of a fixed-dose combination of Sovaldi sofosbuvir and ledipasvir ( GS-5885) from Gilead Sciences Inc. (NASDAQ:GILD) to treat chronic HCV genotype 1 infection in patients who are at high risk of liver decompensation or death. Gilead plans to submit an MAA to EMA for the fixed-dose combination this quarter. The company submitted an NDA to FDA for the combination earlier this month (see BioCentury Extra, Feb. 10).

The European Commission approved Sovaldi, a nucleotide analog HCV NS5B polymerase inhibitor, in January. Ledipasvir is an HCV NS5A protein inhibitor (see BioCentury Extra, Jan. 17). ...