Bristol-Myers Squibb (BMS) announced that 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 BMS in October, FDA is requesting additional data for daclatasvir in combination with other antiviral agents for the treatment of HCV. BMS is in discussions with 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, BMS. “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.”
