Bristol-Myers Squibb Company  today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for daclatasvir, an NS5A complex inhibitor, in combination with other agents for the treatment of hepatitis C (HCV).

The initial daclatasvir NDA submitted to the FDA focused on its use in combination with asunaprevir, an NS3/4A protease inhibitor. Given the withdrawal of asunaprevir by Bristol-Myers Squibb in October, the FDA is requesting additional data for daclatasvir in combination with other antiviral agents for the treatment of HCV. Bristol-Myers Squibb is in discussions with the FDA about the scope of these data.

“Despite the recent advances in the treatment of hepatitis C there remain significant areas of unmet high need in this disease area,” said Francis Cuss, Executive Vice President and Chief Scientific Officer, R&D, Bristol-Myers Squibb. “Our commitment remains to make daclatasvir-based regimens available to help these difficult-to-treat patients achieve cure, and we will continue to collaborate with the FDA to bring daclatasvir to patients in the U.S. as quickly as possible.”

For more details, go to: http://news.bms.com/press-release/bristol-myers-squibb-receives-complete-response-letter-us-food-and-drug-administration&t=635526096632768386