EMA Advisory Committee Recommends AbbVie’s Hepatitis C Drug
The European Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) has granted a positive opinion for the use of AbbVie’s Viekirax (ombitasvir/paritaprevir/ritonavir tablets) + Exviera (dasabuvir tablets) without ribavirin in chronic hepatitis C virus infected genotype 1b (GT1b) patients with compensated cirrhosis (Child-Pugh A).
On January 7, 2016 AbbVie announced that its supplemental new drug application for Viekira Pak was accepted and granted priority review by the US Food and Drug Administration.
Viekirax + Exviera is already approved in the European Union for the treatment of genotype 1 (GT1) chronic hepatitis C virus infection, including patients with compensated cirrhosis. Viekirax is approved in the European Union for the treatment of genotype 4 (GT4) chronic hepatitis C viru infection.