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Will Eisai and Biogen reapply for Leqembi approval in the EU by December 31, 2024?
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Yes • 50%
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Official announcements from Eisai, Biogen, or the European Medicines Agency (EMA)
Story
EU Regulator Rejects Leqembi for Early Alzheimer's Disease; Biogen Stock Falls 6.7%
Jul 26, 2024, 11:23 AM
The European Union's drugs regulator has rejected Eisai and Biogen's Alzheimer's drug, Leqembi, for early Alzheimer's disease, citing concerns over its safety profile. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a negative opinion, stating that the observed effect of Leqembi on delaying cognitive decline does not outweigh the risk of serious adverse events. The decision also noted the drug's slight advantage over placebo on a clinical dementia rating scale. This contrasts with the U.S. regulators, who have granted full approval for the drug. The rejection is a significant setback for Eisai and Biogen, who were seeking to expand sales in the European market. Following the announcement, Biogen's stock fell by 6.7% in pre-market trading.
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