The committee said Leqembi’s effect on delaying cognitive decline does not outweigh “the risk of serious side effects associated with the…
European drug regulators rejected the Alzheimer's treatment Leqembi from Biogen and Eisai, creating another hurdle for the companies as they scramble to boost uptake of the therapy in the U.S.
The regulator said Leqembi's effect on delaying cognitive decline does not outweigh"the risk of serious side effects associated with the medicine."The European Commission, the EU's executive body, has a final say in Leqembi's approval. But it almost always follows the drug regulator's recommendations., Eisai said it is"extremely disappointed" by the regulator's negative recommendation. The company added that it will seek a re-examination of the decision.
Leqembi and Kisunla are milestones in the treatment of Alzheimer's after three decades of failed efforts to develop medicines that can fight the fatal disease.
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