AbbVie a global biopharmaceutical company, today 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 the treatment of 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 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 all major HCV genotypes and for special populations.
“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,” said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie.
*Patients who achieve a sustained virologic response at 12 weeks post treatment (SVR12) are considered cured of hepatitis C.
Filed Under: Drug Discovery