AbbVie's approval application for combo hepatitis C drug set for speedy EMA review

US pharma major AbbVie (NYSE: ABBV) says its marketing authorization application (MAA) has been validated and is now under accelerated assessment by the European Medicines Agency for the 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.

If approved, G/P may provide a shorter treatment duration for genotypes 1-6 (GT1-6) patients without cirrhosis, who make up the majority of HCV patients, and an additional treatment option to patients with compensated cirrhosis (Child-Pugh A). G/P is also intended 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.

Globally, the market for HCV treatments is worth around $12 billion, and is expected to reach up to $28 billion by 2021. Around 40% of revenue is generated in North America.