EU Rejection of Alzheimer’s Drug Is Another Disappointment for Biogen

EU Rejection of Alzheimer’s Drug Is Another Disappointment for Biogen·Barrons.com
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European drug regulators rejected Biogen and Eisai request for approval of their Alzheimer’s medicine Leqembi, pointing to safety and efficacy issues that U.S. regulators looked past when they granted the drug full approval last year. The European Medicines Agency said Friday that it had recommended to the European Commission that it refuse marketing authorization within the European Union for Leqembi because of the drug’s limited benefits and the significant risks associated with it. “The observed effect of Leqembi on delaying cognitive decline does not counterbalance the risk of serious adverse events associated with the medicine,” the EMA said in a new document.

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