Glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) for the treatment of all major chronic hepatitis C virus (HCV) genotypes is filed at EMA.-Abbvie

AbbVie announced that its marketing authorization application (MAA) has been validated and is now under accelerated assessment by the European Medicines Agency (EMA) for the company's 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.

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 special populations. Patient populations studied included GT1-6, those new and experienced to treatment, those with compensated cirrhosis and without cirrhosis and patients 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.

Comment:On December 19, 2016, AbbVie announced its New Drug Application submission for G/P to the FDA for the treatment of GT1-6 chronic HCV. AbbVie remains on track to submit a New Drug Application for G/P in Japan in Q1 2017.