AbbVie's (ABBV) Glecaprevir/Pibrentasvir HCV Regiment Receives FDA Breakthrough Therapy Designation
Get instant alerts when news breaks on your stocks. Claim your 2-week free trial to StreetInsider Premium here.
AbbVie (NYSE: ABBV) 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.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- AstraZeneca (AZN) Announces Significant PFS Data from LYNPARZA Phase III SOLO-2
- Minerva Neurosciences (NERV) Reports Six-Month Data from Phase IIb Trial of MIN-10 in Schizophrenia
- OncoGenex Pharma (OGXI) Announces Strong Survival Data from Apatorsen Phase 2 in MBC
Create E-mail Alert Related CategoriesCorporate News, FDA
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!