EMA Accelerated Assessment for AbbVie’s hepatitis C regimen

pharmafile | January 24, 2017 | News story | Manufacturing and Production, Research and Development AbbVie, EMA, hepatitis C 

AbbVie has announced that its investigational, pan-genotypic regimen of Glecaprevir/Pibrentasvir has been awarded Accelerated Assessment by the European Medicines Agency (EMA) for the treatment of all major chronic hepatitis C virus (HCV) genotypes.

The combination treatment promises to provide an additional treatment option for those suffering from compensated cirrhosis, and also a shorter duration of treatment for genotype 1-6 patients without cirrhosis, which accounts for the majority of HCV sufferers.

The treatment regimen is also designed to tackle specific treatment challenges such as severe chronic kidney disease, and those presented by patients who have not responded to previous direct-acting antiviral (DAA) treatment.

“We are pleased at the potential of our investigational, pan-genotypic regimen and that it has been granted accelerated assessment by the EMA. We will work closely with the EMA as we continue our commitment to potentially provide a cure for as many people living with HCV as possible,” said Michael Severino, executive VP, research and development and CSO at AbbVie. “We believe G/P has the potential to further impact the HCV treatment landscape, shortening the treatment duration to just eight weeks for the majority of people living with chronic HCV without cirrhosis.”

If approved, the regimen could be available to patients in the European Union in the latter half of this year.

Matt Fellows

Related Content

BridgeBio Pharma shares positive feedback from FDA and EMA for phase 3 trial of infigratinib

BridgeBio Pharma has announced positive feedback from the US Food and Drug Administration (FDA) and …


AbbVie’s Aquipta receives MHRA marketing authorisation

AbbVie has announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted a …

Iveric Bio’s marketing authorisation application for avacincaptad pegol accepted by EMA

Astellas Pharma has announced that the European Medicines Agency (EMA) has accepted the marketing authorisation …

Latest content