Posted by Michael Wonder on 02 Feb 2017
U.S. FDA grants priority review to AbbVie for its investigational regimen of glecaprevir/pibrentasvir for the treatment of chronic hepatitis C in all major genotypes
2 February 2017 - The priority designation shortens the regulatory review period from the standard 10 months to six months from the acceptance of the application.
AbbVie today announced that the U.S. FDA has accepted its new drug application and granted priority review for its investigational, pan-genotypic regimen of glecaprevir/pibrentasvir, being evaluated for the treatment of all major genotypes of chronic hepatitis C virus.
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 glecaprevir/pibrentasvir clinical development program, which evaluated more than 2,300 patients in 27 countries across all major chronic hepatitis C virus infection genotypes and for special populations.
