February 26, 2014
This article was reported by Fox Business.
Fox Business reported that the U.S. Food and Drug Administration (FDA) awarded "breakthrough therapy designation" to Bristol-Myers Squibb's investigational treatment for hepatitis C virus (HCV) infection on February 24. This rare designation expedites the development and review process of drugs for serious or life-threatening conditions as FDA puts them on a fast-track approval process and gives the drug manufacturers intensive guidance. The approval for Bristol-Myers' combination therapy of chronic HCV infection comes after preliminary data from an ongoing late-stage trial in which the drug manufacturer is evaluating an all-oral regimen of daclatasvir and asunaprevir without ribavirin.