European regulators are undertaking a speedy review of AbbVie's investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) for the treatment of chronic hepatitis C (HCV) in all major genotypes.
According to the firm, the G/P regimen could provide a shorter, eight week, once-daily, ribavirin-free treatment option for the majority of HCV patients without cirrhosis, as well as an additional treatment option to patients with compensated cirrhosis (Child-Pugh A).
The therapy is also intended to address the needs of patients with specific treatment challenges, such as those with severe chronic kidney disease (CKD) and those not cured with previous direct-acting antiviral (DAA) treatment, it said.
The application contains data from eight registrational studies in AbbVie's G/P clinical development programme, involving more than 2,300 patients across all major HCV genotypes and special populations, which was designed to investigate a faster path to virologic cure for all major genotypes and with the goal of addressing areas of continued unmet need.
"We are pleased at the potential of our investigational, pan-genotypic regimen and that it has been granted accelerated assessment by the EMA," said AbbVie's chief scientific officer Michael Severino. "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".