Posted by Michael Wonder on 24 Jan 2017
European Medicines Agency grants accelerated assessment, validates marketing authorisation application for AbbVie's investigational regimen of glecaprevir/pibrentasvir for the treatment of chronic hepatitis C in all major genotypes
24 January 2017 - Marketing authorisation application is supported by data from global registrational clinical development program across all major HCV genotypes and in patients with specific treatment challenges.
AbbVie today announced that its marketing authorisation application as been validated and is now under accelerated assessment by the EMA for the company's investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) for the treatment of all major chronic hepatitis C virus (HCV) genotypes.
If approved, glecaprevir with pibrentasvir provide a shorter treatment duration for genotypes 1-6 patients without cirrhosis, who make up the majority of HCV patients, and an additional treatment option to patients with compensated cirrhosis (Child-Pugh A). Glecaprevir with pibrentasvir is also intended to address the needs of patients with specific treatment challenges, including those with severe chronic kidney disease and those not cured with previous direct-acting anti-viral treatment.
