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Daclatasvir/Asunaprevir Combo Receives ‘Breakthrough Therapy’ Designation for Hepatitis C
The FDA has granted the dual regimen of daclatasvir and asunaprevir (Bristol-Myers Squibb) a “breakthrough therapy” designation for use in the treatment of genotype 1b chronic hepatitis C virus (HCV) infection.
The designation was based on data from an ongoing phase III clinical trial program evaluating the all-oral combination regimen of daclatasvir, an investigational NS5A replication complex inhibitor, and asunaprevir, an investigational NS3 protease inhibitor, without ribavirin.
According to the FDA, a breakthrough therapy designation is intended to expedite the development and review of drugs for serious or life-threatening conditions.
An estimated 2.7 to 3.9 million people are chronically infected with HCV in the U.S.
Source: Bristol-Myers Squibb; February 24, 2014.