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Home » ARIA swan song for Leqembi in EU? Eisai, Biogen appeal AD opinion
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ARIA swan song for Leqembi in EU? Eisai, Biogen appeal AD opinion

July 26, 2024
By Randy Osborne
Biogen Inc. and partner Eisai Co. Ltd. said the EMA’s Committee for Medicinal Products for Human Use has adopted a negative opinion on the marketing bid for lecanemab in early Alzheimer’s disease (AD) and mild AD. The humanized anti-soluble aggregated amyloid-beta monoclonal antibody is approved in the U.S., Japan, China, South Korea, Hong Kong and Israel, and is being sold in the U.S., where it’s branded Leqembi, as well as Japan and China. Eisai, of Tokyo, will ask the CHMP to re-examine the matter.
BioWorld Regulatory Neurology/psychiatric Monoclonal antibody Asia-Pacific Europe Japan U.S. CHMP EMA

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