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 with paritaprevir and ritonavir)  and Exviera (dasabuvir sodium) 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 CHMP positive opinions mark an important milestone in our HCV development program and recognize the potential our treatment brings to people in Europe living with this chronic condition," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "Our treatment has been developed with the goal of achieving high cure rates in a broad range of genotype 1 patients with low rates of discontinuation and relapse." 

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.

For more details, go to: http://abbvie.mediaroom.com/2014-11-21-CHMP-Grants-Positive-Opinions-of-AbbVies-VIEKIRAX-ombitasvir-paritaprevir-ritonavir-EXVIERA-dasabuvir-for-the-Treatment-of-Chronic-Hepatitis-C-in-Europe