According to the company, data submitted in the NDAs support the use of DCV+ASV in patients with genotype 1b hepatitis C (HCV).
The company also seeks approval for DCV NDA to use the compound in combination with other agents for multiple genotypes.
The submissions are subject to FDA review for acceptance for filing.
BMS senior vice president of Global Development and Medical Affairs, Research and Development Brian Daniels said 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.
"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," Daniels said.
The submissions follow the recent FDA breakthrough therapy designation for the investigational DCV Dual Regimen (DCV+ASV).
Currently, DCV is being studied in the ongoing Phase III UNITY Program, where it is being investigated as part of an all-oral 3DAA Regimen (daclatasvir/asunaprevir/BMS-791325).
The trial populations include non-cirrhotic naïve, cirrhotic naïve and previously treated patients.
Image: A Bristol-Myers Squibb R&D facility Princeton Rd, Princeton, New Jersey, US. Photo: courtesy of Coolcaesar