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No Fast Track For Lecanemab In EU Disappoints Eisai

Pan-EU Approval Could Come In March 2024, Says Company

 
• By Andrew McConaghie

Despite being hailed as a potential breakthrough for Alzheimer’s, the EMA will not fast-track lecanemab, underscoring differences with the US FDA’s frequent use of accelerated pathways.

EMA
Lecanemab could be approved in the European Union by March 2024 - well over a year after the US accelerated approval. • Source: Shutterstock

Eisai’s request for an accelerated assessment of its Alzheimer’s disease candidate lecanemab has been rejected by the European Medicines Agency, a blow to hopes of fast access to the treatment in the EU.

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