Bristol-Myers Squibb (BMS) has received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA) for its investigational DCV Dual Regimen (daclatasvir and asunaprevir) for use as a combination therapy in the treatment of genotype 1b chronic hepatitis C infection (HCV).
The breakthrough therapy designation is based on data from the company's ongoing Phase III clinical trial program that is evaluating the all-oral combination regimen of DCV, an investigational NS5A replication complex inhibitor, and ASV, an investigational NS3 protease inhibitor, without ribavirin.
The designation will help in expediting the development and review of drugs for serious or life-threatening conditions.
Bristol-Myers Squibb senior vice president of Global Development and Medical Affairs, Research and Development Brian Daniels said the FDA's decision to grant Breakthrough Therapy Designation for the company's 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," Daniels said.
Across the world, over 170 million people are infected with hepatitis C, with an estimated 2.7-3.9 million chronically infected in the US.
Recently, the European Medicines Agency (EMA) has validated BMS' marketing authorization application (MAA) for the use of daclatasvir to treat adults with HCV with compensated liver disease, including genotypes 1, 2, 3, and 4.
The MAA seeks the approval of daclatasvir for use in combination with other agents for the treatment of chronic hepatitis C and will be reviewed under an accelerated regulatory review.
