AbbVie announced that the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion for the use of VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) without ribavirin (RBV) in chronic hepatitis C virus (HCV) infected genotype 1b (GT1b) patients with compensated cirrhosis (Child-Pugh A).
The CHMP opinion of the Type-II variation application for VIEKIRAX + EXVIERA is supported by data from the Phase 3b TURQUOISE-III study, which is part of AbbVie's larger clinical program investigating efficacy and safety in a broad range of GT1 patients. TURQUOISE-III is a dedicated Phase 3 study of VIEKIRAX + EXVIERA without RBV for 12 weeks in GT1b patients with compensated cirrhosis. Results from the TURQUOISE-III study showed 100 percent (n=60/60) of GT1b chronic HCV infected patients with compensated cirrhosis (Child-Pugh A) achieved sustained virologic response at 12 weeks post-treatment (SVR12) with VIEKIRAX + EXVIERA without RBV for 12 weeks.No patients discontinued treatment due to adverse events. The most commonly reported adverse events (>10 percent) were fatigue (22 percent), diarrhea (20 percent) and headache (18 percent).
On January 7, AbbVie announced that its supplemental New Drug Application (sNDA) for VIEKIRA PAK® was accepted and granted priority review by the U.S. Food and Drug Administration (FDA).
