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CHMP gives nod to AbbVie's HCV therapies

November 22, 2014 2:24 AM UTC

EMA's CHMP recommended approval of Exviera dasabuvir and Viekirax, which is a two direct-acting-antiviral (2-DAA) combination of ombitasvir and paritaprevir ( ABT-450) plus the booster Norvir ritonavir from AbbVie Inc. (NYSE:ABBV) to treat chronic HCV infection.

CHMP recommended the 3-DAA combination of Viekirax plus Exviera, with or without ribavirin, to treat HCV genotype 1, and recommended Viekirax plus ribavirin to treat HCV genotype 4. EMA is evaluating MAAs for both compounds under accelerated assessment and AbbVie expects a final decision by 1Q15. CHMP said marketing authorization for both products would include a pharmacovigilance plan. ...