U.S. FDA Grants Priority Review For Daklinza (daclatasvir) sNDAs
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Bristol-Myers Squibb (BMY) Announces FDA Acceptance of Three Daklinza SNDAs
October 6, 2015 7:01 AM EDTBristol-Myers Squibb (NYSE: BMY) announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and review three supplemental New Drug Applications (sNDAs) for Daklinza (daclatasvir), an NS5A replication complex inhibitor, for use with sofosbuvir with or without ribavirin. The applications are for the treatment of patients with chronic hepatitis C (HCV) coinfected with human immunodeficiency virus (HIV-1), patients with advanced cirrhosis (including decompensated cirrhosis), and for patients with post-liver transplant recurrence of HCV.
In the U.S., the FDA grants priority review status when an investigational... More
