Bristol-Myers Squibb Company announced that the US Food and Drug Administration (US 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 focussed 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.”
Bristol-Myers Squibb is dedicated to the ongoing clinical development program for daclatasvir, a potent, pan-genotypic NS5A complex inhibitor (in vitro), which is currently being investigated globally in multiple treatment regimens for HCV patients with high unmet need. The company continues to progress its daclatasvir clinical trial programme focussed 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). The phase 3 UNITY studies investigating Bristol-Myers Squibb’s investigational all-oral fixed-dose-combination DCV-TRIO regimen (daclatasvir/asunaprevir/beclabuvir) are also ongoing and include study populations of non-cirrhotic naïve, cirrhotic naïve and previously treated patients.