EMA Committee OKs AbbVie’s Hepatitis C Combo Drug
The European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted positive opinions for AbbVie’s investigational, all-oral, interferon-free treatment of Viekirax (ombitasvir/paritaprevir/ritonavir) + Exviera (dasabuvir) with or without ribavirin (RBV) for patients with Genotype 1 (GT1) and Genotype 4 (GT4) chronic hepatitis C virus (HCV) infection. The European Commission will review the opinions and make a final decision sometime in the first quarter of 2015.
The marketing authorization applications (MAAs) were submitted to the EMA on May 6, 2014 under an accelerated assessment, designated to new medicines of major public health interest. Review of the MAAs is being conducted under the centralized licensing procedure, which if approved will result in marketing authorizations valid in all 28 member states of the European Union, as well as Iceland, Liechtenstein, and Norway.
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.
Paritaprevir was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals for HCV protease inhibitors and regimens that include protease inhibitors. Paritaprevir has been developed by AbbVie for use in combination with AbbVie’s other investigational medicines for the treatment of hepatitis C.