| 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.
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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.
“The CHMP positive opinions mark an important milestone in our HCV development program and recognizes the potential our treatment brings to people in Europe living with this chronic condition,” Michael Severino, MD, executive vice president of research and development and chief scientific officer of AbbVie, said in the press release. “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 all-oral, interferon-free regimen consists of a fixed-dose combination of the protease inhibitor ritonavir, at 100 mg/150 mg, co-formulated with 25 mg ombitasvir, administered once daily, along with 250 mg dasabuvir with or without ribavirin, administered twice daily. The European Medicines Agency (EMA) has granted accelerated assessment for the combination treatment. If approved, the regimen will be available for marketing in all 28 European Union member states.
AbbVie submitted a new drug application for the investigational treatment to the FDA in April. The FDA assigned the treatment breakthrough therapy designation in May 2013, granting it priority review.