FDA Grants Breakthrough Designation To BMS' DCV Dual Therapy

Bristol-Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has assigned Breakthrough Therapy Designation to its investigational DCV dual regimen (daclatasvir and asunaprevir). DCV dual therapy is intended for the treatment of genotype 1b chronic hepatitis C infection (HCV).

Brian Daniels, senior vice president of the Global Development and Medical Affairs, Research and Development at Bristol-Myers Squibb, said, “The FDA’s decision to grant Breakthrough Therapy Designation for our DCV Dual Regimen (daclatasvir and asunaprevir combination therapy) marks the second time that the FDA has granted the designation to a daclatasvir-based regimen, further underscoring its potential to help address the high unmet needs of the HCV patient population. This is an important milestone for Bristol-Myers Squibb as we continue our strategic focus on the development of innovative medicines to address areas of high unmet medical need, where potential expedited review can make a critical difference for patients.”

Hepatitis C is caused by a virus that infects the liver. Up to 90 percent HCV infected individuals become chronically infected and will not be able to get rid of the virus spontaneously. According to the World Health Organization, 20% of patients with chronic hepatitis C will develop cirrhosis, 25% of which may lead to liver cancer.

The U.S. Food and Drug Administration (FDA) assigns breakthrough status to drugs and therapies that have potential for treating serious or life-threatening conditions. FDA criteria for Breakthrough Therapy Designation requires preliminary evidence that shows the drug may have significant improvement on at least one clinically significant endpoint over existing therapies.

The FDA designation is based on results from BMS’ ongoing Phase III trial evaluating the all-oral combination regimen of DCV and ASV without ribavirin. DCV is an NS5A replication complex inhibitor while ASV is an investigational NS3 protease inhibitor. The company expects to present new data from its ongoing Phase III trial at an upcoming scientific forum.