The breakthrough therapy designation, which allows for expedited development and review of therapies for severe or life-threatening conditions, was based on data from the phase 2 MAGELLAN-1 clinical study.
In the study, 95% of patients achieved sustained viral response (SVR)12 with 12 weeks of ABT-493 and ABT-530 with and without ribavirin (RBV) in GT1 chronic HCV infected patients without cirrhosis who failed previous therapy with DAAs in a modified intent-to-treat analysis.
The company said 91% achieved SVR12 with RBV in the primary intent-to-treat analysis, while 86% achieved SVR12 without RBV
AbbVie executive vice president, research and development and chief scientific officer 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."
The company said will present new phase 3 data assessing the safety and efficacy of G/P across all major HCV genotypes (genotypes 1-6) at an upcoming scientific congress.
The regimen includes glecaprevir, an NS3/4A protease inhibitor, and pibrentasvir, an NS5A inhibitor. It is dosed once daily as three oral tablets.
Glecaprevir was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals.
Image: AbbVie US Headquarters. Photo: courtesy of AbbVie Inc.