Thursday, February 2, 2017

U.S. FDA Grants Priority Review to AbbVie’s Investigational HCV Regimen of Glecaprevir/Pibrentasvir (G/P)

Priority review shortens FDA review timelines from ten months to six months. Review studies presented at the Liver Meeting, news articles, and data on glecaprevir/pibrentasvir (G/P) published in peer-reviewed journals, here.

Enanta Announces U.S. FDA Grants Priority Review to AbbVie’s Investigational HCV Regimen of Glecaprevir/Pibrentasvir (G/P) for the Treatment of Chronic Hepatitis C in All Major Genotypes (GT1-6)
  • If approved, G/P may provide an eight-week, once-daily, ribavirin-free cure* for HCV patients new to treatment who have any of the major HCV genotypes, without cirrhosis
  • G/P includes Enanta’s second protease inhibitor, glecaprevir (ABT-493)

WATERTOWN, Mass.--()--Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a research and development-focused biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted AbbVie’s New Drug Application (NDA) for its investigational, pan-genotypic regimen of glecaprevir/pibrentasvir (G/P) being evaluated for the treatment of all major genotypes (GT1-6) of chronic hepatitis C virus (HCV), and has granted the NDA priority review. Glecaprevir is Enanta’s second protease inhibitor being developed through its collaboration with AbbVie and is one of the two new direct-acting antivirals in G/P.
The FDA grants priority review designation to medicines that it determines have the potential to provide significant improvements in the safety and effectiveness of the treatment of a serious disease. The NDA is supported by data from eight registrational studies in AbbVie's G/P clinical development program, which evaluated more than 2,300 patients in 27 countries across major HCV genotypes and special populations.
About AbbVie’s G/P HCV Clinical Development Program
AbbVie’s glecaprevir/pibrentasvir (G/P) clinical development program was designed to investigate a faster path to virologic cure* for all major HCV genotypes (GT1-6) and with the goal of addressing treatment areas of continued unmet need.
G/P is an investigational, pan-genotypic regimen that is being evaluated as a potential cure in 8 weeks for HCV patients without cirrhosis and who are new to treatment, who make up the majority of HCV patients. AbbVie is also studying G/P in patients with specific treatment challenges, such as genotype 3 HCV patients, patients who were not cured with previous DAA treatment, and patients with chronic kidney disease (CKD), including patients on dialysis.
G/P is a once-daily regimen that combines two distinct antiviral agents in a fixed-dose combination of glecaprevir (100mg), an NS3/4A protease inhibitor, and pibrentasvir (40mg), an NS5A inhibitor. G/P (300/120mg) is dosed once-daily as three oral tablets.
Additional information on AbbVie’s clinical trials for G/P is available at
*Patients who achieve a sustained virologic response at 12 weeks post treatment (SVR12) are considered cured of hepatitis C.

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