The FDA has granted Breakthrough Therapy Designation (BTD) for AbbVie’s investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) for the treatment of patients with chronic hepatitis C virus (HCV) who failed previous therapy with direct-acting antivirals (DAAs) in genotype 1 (GT1), including therapy with an NS5A inhibitor and/or protease inhibitor.
The BTD is supported by positive results seen in AbbVie's phase II MAGELLAN-1 clinical study. According to the FDA, BTD is intended to expedite the development and review of therapies for serious or life threatening conditions.
"AbbVie is committed to advancing HCV care and addressing areas of continued unmet need for people living with chronic HCV," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "The FDA's Breakthrough Therapy Designation is an important step in our effort to bring our pan-genotypic regimen to market, which we are also investigating as an eight week path to virologic cure for the majority of patients."
AbbVie will present new phase III data evaluating the safety and efficacy of G/P across all major HCV genotypes (genotypes 1-6) at an upcoming scientific congress.
GLE was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals for HCV protease inhibitors and regimens that include protease inhibitors.