Bristol-Myers Squibb announced that it has submitted New Drug Applications (NDAs) to the FDA for daclatasvir (DCV), an NS5A replication complex inhibitor, and asunaprevir (ASV), an NS3 protease inhibitor, for the treatment of hepatitis C.
The submission for both NDAs was based on data that supports the use of DCV+ASV in patients with genotype 1b hepatitis C (HCV). The daclatasvir NDA also seeks approval for its use in combination with other agents for multiple genotypes.
Previously the FDA granted the investigational DCV Dual Regimen (DCV+ASV) Breakthrough Therapy Designation. In 2013, the investigational all-oral 3DAA Regimen (daclatasvir/asunaprevir/BMS-791325) also received Breakthrough Therapy Designation.
Daclatasvir is currently being studied in the ongoing Phase 3 UNITY Program, where it is being investigated as part of an all-oral 3DAA Regimen (daclatasvir/asunaprevir/BMS-791325). Study populations include non-cirrhotic naïve, cirrhotic naïve, and previously treated patients. The 3DAA Regimen is being studied as a fixed-dose-combination treatment with twice daily dosing. Daclatasvir is also being investigated in combination with sofosbuvir in high unmet need patients, such as pre- and post-transplant patients, HIV/HCV co-infected patients, and patients with genotype 3, as part of the ongoing Phase 3 ALLY Program.
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