ARTICLE | Company News

FDA to rescind breakthrough for BMS's daclatasvir

February 12, 2015 2:23 AM UTC

Bristol-Myers Squibb Co. (NYSE:BMY) said FDA told the company that it plans to rescind breakthrough therapy designations for two HCV regimens containing daclatasvir due to the "evolving HCV treatment landscape."

BMS said the notification includes the dual combination of daclatasvir, an HCV NS5A protein inhibitor, with asunaprevir, an HCV NS3 protease inhibitor, and the triple combination of daclatasvir, asunaprevir and BMS-791325, a non-nucleoside HCV NS5B polymerase inhibitor. ...