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Home Industry News AbbVie receives CHMP recommendation for hepatitis C therapy

AbbVie receives CHMP recommendation for hepatitis C therapy

27th November 2014

AbbVie has been granted a recommendation for European approval of a new combination therapy for hepatitis C.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has endorsed Viekirax plus Exviera with or without ribavirin for the treatment of patients with genotype 1 and 4 chronic hepatitis C virus infection.

An all-oral, interferon-free treatment, the combination has demonstrated its safety and efficacy in six pivotal phase III trials including more than 2,300 patients from over 25 countries.

The European Commission will review the CHMP's opinion and make a final decision some time in the first quarter of 2015.

Dr Michael Severino, executive vice-president for research and development and chief scientific officer at AbbVie, said: "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."

Earlier this month, the company raised its financial guidance for 2014, based on its better-than-expected performance during the third quarter of the year.ADNFCR-8000103-ID-801762702-ADNFCR

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