Bristol-Myers Squibb has submitted new drug applications with US regulators for hepatitis C drugs daclatasvir and asunaprevir.
The data submitted to the US Food and Drug Administration will support the application for the two drugs in combination to treat genotype 1b hepatitis C, while daclatasvir is being sought for use in combination with other agents for multiple genotypes. The FDA has recently granted the drug combination 'breakthrough therapy designation'.
The US application marks the third major regulatory milestone for daclatasvir after the European Medicines Agency validated the company’s marketing authorisation for the use of the drug in combination with other agents to treat HCV with compensated liver disease in January. Japan is also considering the drugs under priority review.
“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, head of global development and medical affairs at BMS. “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.”
BMS also has been granted BTD for the investigational all-oral 3DAA regimen (daclatasvir/asunaprevir/BMS-791325), which the firm hopes to submit for FDA review in the first quarter of 2015.