November 21, 2014
The European Committee for Medicinal Products for Human Use, or CHMP, granted a positive opinion for the recommendation of Viekirax plus Exviera, with or without ribavirin, for the treatment of chronic hepatitis C genotype 1 and 4 infection, according to a press release.
The Viekirax (omitasvir/paritaprevir/ritonavir, AbbVie) and exviera (dasabuvir, AbbVie) combination was looked upon favorably based on data from multiple phase 3 studies — SAPPHIRE-I, SAPPHIRE-II, PEARL-II, PEARL-III, PEARL-IV and TURQUOISE-II. The CHMP’s recommendation will be addressed by the European Commission, which has the authority to approve the drug for the European Union. More than 2,300 patients have been included in the studies with the direct-acting antiviral regimen, and the treatment has been generally well tolerated.