No Fast Track For Lecanemab In EU Disappoints Eisai

Approval Could Come March 2024

19 Jan 2023

Despite being hailed as a potential breakthrough for Alzheimer’s, the EMA will not fast-track lecanemab, underscoring differences with the 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.

The drug has been tipped as a potential blockbuster for Eisai and its partner Biogen, but gaining full regulatory...