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What will be the next major regulatory decision on Leqembi by December 31, 2024?
2
Resolution / Starting Odds
Approval in another major market • 25%
Rejection in another major market • 25%
Reapplication in the EU • 25%
No major decision • 25%
Official announcements from regulatory bodies like the EMA, FDA, or other major market regulators
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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Approved without restrictions • 25%
Approved with restrictions • 25%
Rejected • 25%
Decision delayed • 25%
Yes • 50%
No • 50%
European Union • 25%
Japan • 25%
Canada • 25%
Other • 25%
Yes • 50%
No • 50%
Approved • 33%
Rejected • 33%
Request for more data • 34%
Yes, by Eisai/Biogen • 25%
Yes, by regulatory mandate • 25%
No, no price reduction • 25%
Other • 25%
Uphold current decision • 25%
Overturn current decision • 25%
Remand for further proceedings • 25%
Other • 25%