On April 7, Bristol-Myers Squibb (BMS) filed new drug applications (NDAs) with the U.S. Food and Drug Administration for the NS5A replication complex inhibitor daclatasvir and the NS3 protease inhibitor asunaprevir to be used in combination to treat genotype 1b of hepatitis C virus (HCV). BMS’s daclatasvir application also asks the FDA to approve the drug for use in combination with other hep C meds to treat multiple genotypes of the virus.

“These FDA submissions represent a major step towards offering daclatasvir-based regimens to U.S. HCV patients, many of whom continue to have high unmet medical needs,” Brian Daniels, MD, senior vice president of global development and medical affairs, research and development at BMS, said in a release. “We are excited to have achieved this milestone and, looking forward, will continue to innovate and invest in daclatasvir in a range of patient types and regimens.”

The FDA has already granted the combination of daclatasvir and asunaprevir with a Breakthrough Therapy Designation. BMS also received this designation for a triple-drug therapy including daclatasvir, asunaprevir and BMS-791325. BMS expects to submit an NDA for the three-drug cocktail in early 2015.

To read the press release, click here.