EU Body Rejects Alzheimer's Drug by Biogen, Eisai
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Brussels, Dec. 17 (Jiji Press)--The European Medicines Agency said Friday that it has recommended the refusal of the marketing authorization for the new Alzheimer's disease drug jointly developed by U.S. biopharmaceutical company Biogen Inc. and Japan's Eisai Co. <4523>.
The European Union regulatory body could not confirm the effectiveness and safety of the drug, aducanumab, in clinical trials.
The drug, whose product name is Aduhelm, is drawing attention as the first medicine that acts on a substance believed to cause the disease.
Biogen said the same day that it will "seek a re-examination" by the EMA.
Japan's health ministry plans to discuss whether to approve the drug at a panel meeting Wednesday.
[Copyright The Jiji Press, Ltd.]