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BRUSSELS (Jiji Press) — The European Medicines Agency said Friday that it has recommended 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. .
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.
The EMA said the link between the drug’s effectiveness in reducing the substance that causes the disease and clinical improvement “had not been established.”
“Results from the main studies were conflicting and did not show overall that Aduhelm was effective at treating adults with early stage Alzheimer’s disease,” the EMA said.
“In addition, the studies did not show that the medicine was sufficiently safe as images from brain scans of some patients showed abnormalities suggestive of swelling or bleeding, which could potentially cause harm, “ it added.
The drug was approved in the United States in June through fast-track procedures. The practical use of the drug already started in the country.
But its sales have been sluggish, as some people have questioned its effectiveness, informed sources said.
