BioCentury
ARTICLE | Company News

CHMP recommends HCV combos, spurns Ninlaro

May 28, 2016 1:05 AM UTC

EMA's CHMP recommended approval of HCV therapies from Gilead Sciences Inc. (NASDAQ:GILD) and Merck & Co Inc. (NYSE:MRK), but recommended against approving cancer compound Ninlaro ixazomib from Takeda Pharmaceutical Co. Ltd. (Tokyo:4502).

CHMP backed approval of Epclusa sofosbuvir/velpatasvir, Gilead's pan-genotypic HCV treatment. The combination therapy is a fixed-dose combination of pan-genotypic HCV NS5A inhibitor velpatasvir ( GS-5816) and nucleotide analog HCV NS5B polymerase inhibitor Sovaldi sofosbuvir. Gilead markets Sovaldi to treat HCV genotypes 1, 2, 3 and 4. The pan-genotypic combo is under FDA review, with a June 28 PDUFA date. ...