AbbVie Gets EU Nod for Hepatitis C TherapyBy
The European Commission has granted marketing authorizations for AbbVie’s all-oral, short-course, interferon-free treatment of Viekirax (ombitasvir/paritaprevir/ritonavir tablets) + Exviera (dasabuvir tablets). The treatment has been approved with or without ribavirin (RBV) for patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection, including those with compensated liver cirrhosis, HIV-1 co-infection, patients on opioid substitution therapy and liver transplant recipients. Additionally, Viekirax has been approved for use with RBV in genotype 4 (GT4) chronic hepatitis C patients.
Viekirax consists of the fixed-dose combination of paritaprevir 15 0mg (NS3/4A protease inhibitor) and ritonavir 100 mg with ombitasvir 25mg (NS5A inhibitor), dosed once daily, and Exviera consists of dasabuvir 250 mg (non-nucleoside NS5B polymerase inhibitor) dosed twice daily taken with or without ribavirin, dosed twice daily.
With this approval, AbbVie’s treatment is now licensed for use in all 28 member countries of the European Union(EU) and was previously approved in the US Canada, Switzerland, Iceland, Liechtenstein, and Norway. The approval in the EU follow a review under accelerated assessment by the European Medicines Agency, designated to new medicines of major public health interest.
Paritaprevir, one of the active ingredients in Vierkirax, was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals for hepatitis C protease inhibitors and regimens that include protease inhibitors. Paritaprevir was developed by AbbVie for use in combination with AbbVie’s other investigational medicines for the treatment of chronic hepatitis C.