North Chicago-based AbbVie said its investigational treatment of the hepatitis C virus infection has been designated as a breakthrough therapy by the U.S. Food and Drug Administration.
The designation is based, in part, on positive data from AbbVie's clinical development program, including a clinical trial known as "Aviator." The Aviator study was conducted in 571 patients infected with HCV GT1. Results from the treatment demonstrated that the regimen provided high sustained viral response rates with 12 weeks of therapy in patients who had not been previously treated and in those who had failed prior therapy with pegylated interferon and ribavirin.
According to the FDA, Breakthrough Therapy designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. The criteria for Breakthrough Therapy designation includes preliminary clinical evidence demonstrating a drug may have substantial improvement on at least one clinically significant endpoint compared to available therapy. A Breakthrough Therapy designation conveys all of the fast track program features, as well as more intensive FDA guidance on an efficient drug development program.(1)
"AbbVie is pleased that the FDA has granted Breakthrough Therapy designation to our 3-DAA combination with and without ribavirin. We feel it reflects the potential of this regimen to be important in the treatment of HCV," said John M. Leonard, M.D., senior vice president and chief scientific officer, AbbVie. "Our HCV program is one part of our advancing pipeline which is focused on delivering innovative therapies to address pressing areas of unmet clinical need."