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Will Leqembi be approved by another major regulatory body by end of 2025?
2
Resolution / Starting Odds
Yes • 50%
No • 50%
Official announcements from major international regulatory bodies
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EMA Recommends Leqembi for Early Alzheimer's in Patients with ApoE4 Gene; Biogen Shares Rise 5%
Nov 14, 2024, 04:16 PM
The European Medicines Agency (EMA) has recommended the approval of Leqembi, a drug developed by Eisai and Biogen, for the treatment of early Alzheimer's disease. This decision comes after the agency initially rejected the treatment months prior. The recommendation was made by the Committee for Medicinal Products for Human Use (CHMP) and pertains specifically to patients with one or no copies of the ApoE4 gene. The drug has been shown to slow cognitive decline in these patients. Following the announcement, Biogen's shares rose by as much as 5%. The final verdict from the European Commission is still pending.
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Yes • 50%
No • 50%
Approval in another major market • 25%
Rejection in another major market • 25%
Reapplication in the EU • 25%
No major decision • 25%
Yes • 50%
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Only FDA • 25%
FDA and EMA • 25%
FDA, EMA, and MHRA • 25%
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European Medicines Agency (EMA) • 25%
Medicines and Healthcare products Regulatory Agency (MHRA) • 25%
Therapeutic Goods Administration (TGA) • 25%
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Approved in USA only • 25%
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Approved in both USA and EU • 25%
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European Union • 25%
Japan • 25%
Canada • 25%
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FDA (USA) • 25%
EMA (EU) • 25%
MHRA (UK) • 25%
Other • 25%
