Enanta Pharmaceuticals, Inc., announced that a European Medicines Agency (EMA) panel has given a positive review to the use of Viekirax (ombitasvir/paritaprevir/ritonavir tablets) plus Exviera (dasabuvir) without ribavirin (RBV) for the treatment of chronic hepatitis C virus (HCV) infected genotype 1b (GT1b) patients with compensated cirrhosis (Child-Pugh A).
Genotype 1 is the most common type of HCV, accounting for about 60 percent of all diagnoses worldwide. In the European Union, the most commonly found sub-genotype is 1b, estimated to account for 47 percent of the nearly 9 million people infected.
The opinion by the EMA Committee for Medicinal Products for Human Use (CHMP) on the pending application for the label expansion of Viekirax plus Exviera is backed by data from AbbVie’s Phase 3 clinical trial, TURQUOISE-III, which evaluated Viekirax plus Exviera without RBV for 12 weeks in GT1b chronic HCV infected patients with compensated cirrhosis.
Trial results found that 100 percent of treated patients achieved a sustained virologic response at the conclusion of treatment. None needed to discontinue the trial due to adverse effects, of which the most commonly reported were fatigue (22 percent), diarrhea (20 percent), and headache (18 percent).
Paritaprevir is the company’s lead protease inhibitor, identified within the ongoing Enanta-AbbVie collaboration, and is one of the direct-acting antivirals in AbbVie’s Viekirax plus Exviera regimen for the treatment of chronic HCV.
AbbVie recently announced that its supplemental New Drug Application (sNDA) for a similar label expansion for Viekira Pak (a multipill, antiviral combination of dasabuvir, ombitasvir, paritaprevir, and ritonavir) was accepted by the U.S. Food and Drug Administration (FDA) and given priority review.
Viekirax plus Exviera is already approved in the European Union for the treatment of genotype 1 chronic HCV infection, including in patients with compensated cirrhosis.
Enanta is a research and development biotech that uses a chemistry-driven approach to create small molecule drugs for viral infections and liver conditions. The company has developed protease inhibitors and NS5A inhibitors, members of the direct-acting-antiviral (DAA) inhibitor class, designed to specifically target HCV. The protease inhibitors developed in partnership with AbbVie include paritaprevir and ABT-493.