AbbVie's Investigational HCV Regimen Receives U.S. FDA Breakthrough Therapy Designation
Sep 30, 2016
- 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.
About AbbVie's Clinical Development Program
AbbVie's HCV clinical development program is intended to advance scientific knowledge and clinical care of people with chronic HCV infection by investigating a pan-genotypic (genotypes 1-6) regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P). G/P is currently in Phase 3 of clinical development.
AbbVie's investigational regimen includes glecaprevir (GLE), an NS3/4A protease inhibitor, and pibrentasvir (PIB), an NS5A inhibitor dosed once daily as three oral tablets.
GLE was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors.
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.
Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry.
Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2015 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
1 U.S. Food and Drug Administration. Fact Sheet: Breakthrough Therapies.
Accessed September 1, 2016.
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