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Asunaprevir NDA Withdrawal Likely To Mean Daclatasvir Delay

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.

Bristol-Myers Squibb Co.’s strategic decision to no longer seek FDA approval of a two-drug combination of its protease inhibitor asunaprevir and NS5A inhibitor daclatasvir for hepatitis C could mean a later approval for daclatasvir as a solo agent, but the firm is working with FDA on amending the application.

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