The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding Bristol-Myers Squibb's (BMS) new drug application (NDA) for daclatasvir, an NS5A complex inhibitor, in combination with other agents to treat hepatitis C virus (HCV).
The initial daclatasvir NDA submitted by the company to the FDA focused on the drug’s use in combination with asunaprevir, an NS3/4A protease inhibitor.
Given the withdrawal of asunaprevir by BMS in October, the FDA is requesting additional data for daclatasvir in combination with other antiviral agents for HCV treatment.
The company is currently in discussions with the US FDA about the scope of these data.
Bristol-Myers Squibb executive vice-president and chief scientific officer R&D Francis Cuss 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."
The company is dedicated to the ongoing clinical development program for daclatasvir, which is currently being evaluated globally in multiple treatment regimens for HCV patients with high unmet need.
The daclatasvir clinical trial program is focused on difficult-to-treat patients, including pre- and post-liver transplant (ALLY-1), HCV patients co-infected with HIV (ALLY-2) and patients with genotype 3 (ALLY-3).