Asunaprevir NDA Withdrawal Likely To Mean Daclatasvir Delay
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Bristol pulls NDA for its second-generation protease inhibitor, which likely will alter the data needed for approval of its simultaneously filed NS5A inhibitor. Recent approval of daclatasvir in Europe may offer a glimpse at Bristol’s revised U.S. strategy in HCV.