Enanta Pharmaceuticals Inc.'s New Drug Application (NDA) for its pan-genotypic regimen of glecaprevir/pibrentasvir (G/P), developed in conjunction with AbbVie, has been accepted by the U.S Food and Drug Administration.
The FDA gave the product, which was created to treat all major genotypes (GT1-6) of chronic hepatitis C virus (HCV), priority review. In making the decision, the FDA reviewed AbbVie’s G/P clinical development program, which evaluated more than 2,300 patients in 27 countries across major HCV genotypes and special populations.
The drug is the second protease inhibitor Enanta has collaborated on with AbbVie, and is one of its two new direct-acting antivirals.
Enanta Pharmaceuticals is a research and development-centric biotechnology company that creates small molecule drugs to treat liver infections and liver diseases. Enanta currently focuses its efforts on combatting non-alcoholic steatohepatitis/ primary biliary cholangitis, respiratory syncytial virus and hepatitis B virus.
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