Bristol-Myers Squibb's all-oral regimen gains FDA breakthrough therapy status for hepatitis C

Bristol-Myers Squibb announced Monday that its experimental all-oral regimen of daclatasvir and asunaprevir has been granted breakthrough therapy status by the FDA for the treatment of patients with genotype 1b chronic hepatitis C virus (HCV) infection. The drugmaker said that the designation was based on its ongoing Phase III trial assessing the dual regimen.

The company noted that data from the study, which is investigating daclatasvir, an NS5A replication complex inhibitor, and asunaprevir, an NS3 protease inhibitor, with or without ribavirin, will be presented at an upcoming scientific meeting. Meanwhile, results from a separate late-stage study of the combination in Japanese patients with genotype 1b HCV infection who were unsuitable for interferon-based therapies served as the basis for a regulatory submission in the country in October last year.

Brian Daniels, Bristol-Myers Squibb's senior vice president of global development and medical affairs, research and development, noted that the US regulator's decision "marks the second time that the FDA has granted the designation to a daclatasvir-based regimen." Last year, the company's all-oral regimen of daclatasvir, asunaprevir and BMS-791325 was awarded breakthrough therapy status by the agency.

Additionally, the European Medicines Agency recently validated Bristol-Myers Squibb's submission for the use of daclatasvir in combination with other agents, including Gilead Sciences' Sovaldi (sofosbuvir), for the treatment of adults with chronic HCV with compensated liver disease.

To read more Top Story articles, click here.