BioCentury
ARTICLE | Company News

FDA narrows breakthrough designation for BMS HCV combo

May 21, 2015 1:56 AM UTC

Bristol-Myers Squibb Co. (NYSE:BMY) said a combination of its daclatasvir ( BMS-790052) and Sovaldi sofosbuvir from Gilead Sciences Inc. (NASDAQ:GILD) received an amended breakthrough therapy designation from FDA to treat HCV genotype 1 infection in patients with advanced cirrhosis and patients who develop recurrent HCV genotype 1 post-liver transplant. The combination previously had breakthrough designation to treat HCV genotype 1.

An NDA for daclatasvir plus Sovaldi is under review by FDA to treat HCV genotype 3. BMS spokesperson Rob Perry declined to give a timeline for an sNDA submission for the combo to treat the new breakthrough indication. Daclatasvir is a selective HCV NS5A protein inhibitor, and Sovaldi is a nucleotide analog HCV NS5B polymerase inhibitor. ...