US FDA requests additional data for Bristol-Myers Squibb's daclatasvir

US pharma major Bristol-Myers Squibb (NYSE: BMY) has received a Complete Response Letter from the US Food and Drug Administration regarding its New Drug Application for hepatitis C drug daclatasvir.

Daclatasvir, an NS5A complex inhibitor, is used 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's NDA by B-MS in October, the FDA is requesting additional data for daclatasvir in combination with other antiviral agents for the treatment of HCV. B-MS said it is in discussions with the FDA about the scope of these data.

Francis Cuss, B-MS’ executive vice president and chief scientific officer, R&D, said: “Despite the recent advances in the treatment of hepatitis C there remain significant areas of unmet high need in this disease area. 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 US as quickly as possible.”