Feb 02, 2017
AbbVie, a global biopharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) and granted priority review for its investigational, pan-genotypic regimen of glecaprevir/pibrentasvir (G/P), being evaluated for treating all major genotypes (GT1-6) of chronic hepatitis C virus (HCV). The FDA grants priority review designation to medicines that it determines have the potential to deliver substantial improvements in the effectiveness and safety of the treatment of a serious disease. The NDA is supported by data from eight registrational studies in the G/P clinical development program of Abbvie, which evaluated more than 2,300 patients in 27 countries across all major HCV genotypes and for special populations.
Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie, said: “We are pleased that G/P has been granted priority review by the FDA. We will continue to work closely with the agency as they review our New Drug Application and we remain committed to bringing a new cure to patients with chronic hepatitis C.”