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- Breakthrough Therapy Designation granted based on Phase 2 clinical data for genotype 1 (GT1) patients who failed previous therapy with direct-acting antivirals (DAAs)
- Currently in Phase 3 clinical trials, glecaprevir/pibrentasvir (G/P) is an investigational, pan-genotypic regimen being evaluated for the treatment of chronic hepatitis C virus (HCV) genotypes 1-6
- Breakthrough Therapy Designation is granted to investigational treatments for serious or life-threatening conditions with preliminary clinical evidence that may demonstrate substantial improvement over existing therapies
NORTH CHICAGO, Ill., Sept. 30, 2016 /PRNewswire/ — AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for the 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 2 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.1
“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 3 data evaluating the safety and efficacy of G/P across all major HCV genotypes (genotypes 1-6) at an upcoming scientific congress. Additional information on the clinical trials for G/P is available at www.clinicaltrials.gov.
Read complete press release here: https://news.abbvie.com/news/abbvies-investigational-hcv-regimen-receives-us-fda-breakthrough-therapy-designation.htm