FDA Grants Priority Review to Three BMS sNDAs for Daklinza

The FDA has granted priority review status for three sNDAs for Bristol-Myers Squibb’s Daklinza, potentially expanding the firm’s footprint in the roughly $13 billion U.S. hepatitis C market.

The sNDAs are for Daklinza (daclatasvir) plus sofosbuvir, with or without ribavirin, to treat patients with chronic HCV who are coinfected with HIV-1, patients with advanced cirrhosis and those whose infection recurred after a liver transplant, the drugmaker said last week.

The HCV with advanced cirrhosis and post-transplant HCV recurrence indications received breakthrough therapy designation in May. The new submissions include data from two clinical trials evaluating the once-daily 12-week combination of Daklinza and sofosbuvir (Gilead Sciences’ Harvoni) in the targeted subpopulations. — Jonathon Shacat