Enanta Pharmaceuticals, Inc. announced that AbbVie’s marketing authorization application (MAA) for its investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) for the treatment of all major chronic hepatitis C virus (HCV) genotypes, has been validated by the European Medicines Agency (EMA) and is now under accelerated assessment. If approved, G/P may provide shorter treatment duration for patients infected with any of HCV genotypes 1-6 (GT1-6) and without cirrhosis, who represent the majority of HCV patients. G/P is also intended to provide an additional treatment option to patients with compensated cirrhosis (Child Pugh A) and to address the needs of patients with specific treatment challenges, including those with severe chronic kidney disease (CKD) and those not cured with previous direct-acting-antiviral (DAA) treatment. The Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the EMA, will review the G/P regimen under accelerated assessment, which is the EMA’s designation for new medicines of major public health interest and therapeutic innovation, and is designed to bring new treatments to patients more quickly. Validation of the MAA confirms that the submission is complete and starts the EMA's centralized review process. If approved, AbbVie's G/P regimen could become available for marketing in the European Union (EU) in the second half of 2017. The MAA 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 several special populations. Patient populations studied included GT1-6, those new and experienced to treatment, those with compensated cirrhosis and without cirrhosis, and those with specific treatment challenges, including those with severe CKD, and those not cured with a prior DAA-containing regimen. The program was designed to investigate a faster path to virologic cure for all major HCV genotypes (GT1-6) and with the goal of addressing areas of continued unmet need.