Bristol-Myers Squibb files for US approval of daclatasvir and asunaprevir for hepatitis C

US pharma major Bristol-Myers Squibb (NYSE: BMY) has submitted New Drug Applications with the US Food and Drug Administration for the investigational products daclatasvir (DCV), an NS5A replication complex inhibitor, and asunaprevir (ASV), a NS3 protease inhibitor.

The data submitted in the NDAs support the use of DCV+ASV in patients with genotype 1b hepatitis C (HCV). The DCV NDA also seeks approval for use of this compound in combination with other agents for multiple genotypes. The submissions are subject to FDA review for acceptance for filing.

“These FDA submissions represent a major step towards offering daclatasvir-based regimens to US HCV patients, many of whom continue to have high unmet medical needs,” said Brian Daniels, senior vice president, global development and medical affairs, R&D, at Bristol-Myers Squibb.