AbbVie Inc. (ABBV) said Friday that the European Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency or EMA has granted positive opinions for the company's investigational, all-oral, interferon-free treatment of VIEKIRAX (ombitasvir/paritaprevir/ritonavir) + EXVIERA (dasabuvir) with or without ribavirin or RBV for patients with genotype 1 (GT1) and genotype 4 (GT4) chronic hepatitis C virus or HCV infection.
The company noted that the European Commission will review the opinions and make a final decision sometime in the first quarter of 2015.
The CHMP opinions are supported by a robust clinical development program consisting of six pivotal Phase 3 studies (SAPPHIRE-I, SAPPHIRE-II, PEARL-II, PEARL-III, PEARL-IV and TURQUOISE-II) including more than 2,300 GT1 patients in over 25 countries.
In addition, the positive opinions were supported by a Phase 2 study, PEARL-I, in GT4 patients without cirrhosis, as well as preliminary data from the TURQUOISE-I study in GT1 HCV and HIV-1 co-infected patients and from the CORAL-I study in liver transplant recipients with recurrent GT1 HCV infection who were new to treatment after transplantation.
VIEKIRAX + EXVIERA is being investigated for the treatment of genotype 1 chronic hepatitis C virus (HCV) infection, including patients with compensated cirrhosis. VIEKIRAX consists of the fixed-dose combination of paritaprevir 150mg (NS3/4A protease inhibitor) and ritonavir 100mg with ombitasvir 25mg (NS5A inhibitor), dosed once daily, and EXVIERA consists of dasabuvir 250mg (non-nucleoside NS5B polymerase inhibitor) dosed twice daily, with or without ribavirin, dosed twice daily.
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