FDA Grants Priority Review to Expanded Viekira Pak Indication

Novel HCV Infection Combo Tx Gets FDA OK
Novel HCV Infection Combo Tx Gets FDA OK

Enanta Pharmaceuticals announced that the Food and Drug Administration (FDA) has accepted and granted Priority Review to AbbVie's supplemental New Drug Application (sNDA) for Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) without ribavirin (RBV). Viekira Pak is for the treatment of patients with genotype 1b (GT1b) chronic hepatitis C virus (HCV) and compensated cirrhosis (Child-Pugh A).

The sNDA submission is based on the TURQUOISE-III study, a multicenter, open-label, Phase 3b trial. The trial evaluated the safety and efficacy of Viekira Pak without RBV in 60 adult patients with GT1b chronic HCV infection and compensated liver cirrhosis who were treatment-naïve or treatment-experienced (failed previous pegylated interferon and RBV therapy) for 12 weeks. Results showed 100% sustained virologic response 12 weeks after treatment (SVR12), meeting the study's primary endpoint.

RELATED: FDA to Review New Once Daily Viekira Pak Formulation

Viekira Pak, a combination of ombitasvir, paritaprevir, ritonavir, and dasabuvir, is currently indicated for chronic HCV genotype 1 infection, with or without ribavirin, including those with compensated cirrhosis. Paritaprevir is Enanta's lead protease inhibitor identified within the ongoing Enanta-AbbVie collaboration.

For more information visit Enanta.com.


Loading links....