Posted by Michael Wonder on 30 Sep 2016
AbbVie's investigational HCV regimen receives U.S. FDA breakthrough therapy designation
30 September 2016 - Breakthrough therapy designation granted based on Phase 2 clinical data for genotype 1 patients who failed previous therapy with direct-acting antivirals.
AbbVie today announced that the U.S. FDA has granted breakthrough therapy designation for the investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) for the treatment of patients with chronic hepatitis C virus who failed previous therapy with direct-acting antivirals in genotype 1, including therapy with an NS5A inhibitor and/or protease inhibitor.
