Positive EMA/CHMP opinion for AbbVie's Viekirax + Exviera

29 February 2016

US biopharma company AbbVie (NYSE: ABBV) says that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has granted a positive opinion for the use of Viekirax (ombitasvir/paritaprevir/ritonavir tablets) + Exviera (dasabuvir tablets) without ribavirin (RBV) in chronic hepatitis C virus (HCV) infected genotype 1b (GT1b) patients with compensated cirrhosis (Child-Pugh A).

"This positive CHMP opinion brings us one step closer to delivering a ribavirin-free treatment option for GT1b patients with compensated cirrhosis that has demonstrated high cure rates with no treatment discontinuations in our clinical trial," said Michael Severino, executive vice president, R&D, and chief scientific officer, AbbVie.

Around 160 million people worldwide are infected with HCV. Genotype 1 is the most common type of HCV genotype, accounting for 60% of cases worldwide. In Europe, the most prevalent genotype is Ib, accounting for 47%of the nine million people infected with chronic HCV.

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