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Home Industry News Bayer receives positive CHMP opinion on Nexavar

Bayer receives positive CHMP opinion on Nexavar

24th September 2007

Bayer HealthCare and Onyx Pharmaceuticals have announced that Nexavar (sorafenib) has received a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP), with the committee recommending the approval of the compound as a treatment for hepatocellular carcinoma.

This recommendation is based on data from a phase III clinical study of the compound that showed the drug to extend survival in hepatocellular carcinoma patients by 44 per cent, while adverse affects in patients receiving Nexavar and those administered with placebo were comparable.

Nexavar is currently approved for use in over 50 countries worldwide – including those in the European Union – as a treatment for advanced kidney cancer.

Gunnar Riemann, member of the Bayer HealthCare executive committee, said: “The positive opinion issued by the CHMP marks another significant milestone for Nexavar in liver cancer.

“The committee’s decision underscores the potential of Nexavar to become the standard systemic drug therapy for the treatment of liver cancer.”

Hollings Renton, chairman, president and chief executive officer at Onyx, welcomed the recommendation by the CHMP and that of the US Food and Drug Administration to give priority review status to the drug.

Last month, Bayer and Onyx reported positive clinical trial results showing the efficacy and tolerability of Nexavar across ethnic groups and geographies.

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