FDA grants AbVie’s G/P regimen Breakthrough Therapy Designation

AbbVie's investigational, pan-genotype regimen of gelcaprevir (ABT-493) and pibrentasvir (ABT-530) (G/P) has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration.

The investigational G/P regimen is designed to treat chronic hepatitis C virus (HCV) in patients who have had undergone past therapies involving direct-acting antivirals (DAAs) in genotype 1 (GT1) that have failed.

"AbbVie is committed to advancing HCV care and addressing areas of continued unmet need for people living with chronic HCV," AbbVie Executive Vice President of Research and Development and Chief Scientific Officer Dr. Michael Severino said. "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’s G/P regimen was granted BTD due to the positive results of the MAGELLAN-1 Phase 2 trial. With the BTD, development and therapy reviews for life threatening conditions can be fast-tracked.

Next for AbbVie will be the presentation of the Phase 3 data, assessing the safety and effectiveness of the G/P regimen in regard to all major HCV genotypes, at the forthcoming scientific congress.