FDA Oks AbbVie' VIEKIRA XR To Treat Genotype 1 Chronic Hepatitis C Virus

(RTTNews) - Enanta Pharmaceuticals Inc., (ENTA) announced that the U.S. Food and Drug Administration has approved AbbVie's New Drug Application or NDA for VIEKIRA XR (dasabuvir, ombitasvir, paritaprevir and ritonavir) extended release tablets.

VIEKIRA XR is a once-daily, extended-release co-formulation of the active ingredients in VIEKIRA PAK(ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) and is for the treatment of patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection, including those with compensated cirrhosis (Child-Pugh A). VIEKIRA XR is not for HCV patients with decompensated cirrhosis.

Paritaprevir is Enanta's lead protease inhibitor identified within the ongoing Enanta-AbbVie collaboration and is one of the three direct-acting antivirals in AbbVie's VIEKIRA XR.

The approval of VIEKIRA XR is supported by data from seven Phase 3 clinical trials in more than 2,300 patients who received VIEKIRA PAK with or without RBV for 12 or 24 weeks and two bioavailability studies comparing the two formulations.