Bristol-Myers: FDA blocks hepatitis C drug daclatasvir as part of combo, requires more data

NEW YORK, N.Y. – U.S. regulators have declined to approve Bristol-Myers Squibb’s daclatasvir as part of a combination hepatitis C treatment with another antiviral drug called asunaprevir.

The company says data it submitted to the Food and Drug Administration to win approval of daclatasvir focused on that drug’s use with asunaprevir.

However, the New York-based drugmaker in October withdrew its application for approval of asunaprevir. The FDA then requested more data on the effects of daclatasvir in combination with other drugs for treating hepatitis C, currently one of the hottest areas in drug research.

Bristol-Myers Squibb Co., which has a strong focus on drugs for viruses, cancer and gene-related disorders, says it’s now discussing with the FDA the scope of additional data needed.

The company says it is committed to further testing of daclatasvir.