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Market
Will Leqembi be approved by the European Medicines Agency (EMA) by July 26, 2025?
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Resolution / Starting Odds
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No • 50%
Official announcements from the European Medicines Agency (EMA)
Story
CHMP Recommends EU Rejection of Eisai and Biogen's Alzheimer's Drug Leqembi
Jul 26, 2024, 11:19 AM
On July 26, 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion on lecanemab, also known as Leqembi, an Alzheimer's therapy developed by Eisai and Biogen, recommending its rejection in the European Union. This decision diverges from the stance of U.S. regulators, who have approved the medicine. The rejection is a significant setback for Eisai and Biogen, who were seeking to expand sales of the drug in Europe.
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Approval in another major market • 25%
Rejection in another major market • 25%
Reapplication in the EU • 25%
No major decision • 25%
