Bristol-Myers Squibb announced on Monday that it submitted new drug applications with the United States Food and Drug Administration for daclatasvir and asunaprevir, which are used to treat 1b hepatitis C.
"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" Bristol-Myers Global Development and Medical Affairs Research and Development Senior Vice President Brian Daniels said. "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."
DCV is a NS5A replication complex inhibitor and ASV is a NS3 protease inhibitor. Data for the NDAs support the use of the drugs together to treat the disease. The NDA for DCV also requests approval for the drug to be used in combination with other agents.
The applications come after the FDA approved the investigational DCV Dual Regimen to receive Breakthrough Therapy Designation.
Hepatitis C affects the liver and is transmitted through contact with blood and blood products. The virus is widespread, with between 2.7 million and 3.9 million people chronically infected in the U.S. The World Health Organization estimates that approximately 20 percent of people with chronic hepatitis C will develop cirrhosis.