Update on regulatory review of lecanemab for early Alzheimer’s disease in the European Union

Eisai

26 July 2024 - Eisai and Biogen announced today that the CHMP of the EMA has adopted a negative opinion on the marketing authorisation approval for the humanised anti-soluble aggregated amyloid-beta monoclonal antibody lecanemab as treatment for early AD (mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD).

Eisai will seek re-examination of the CHMP opinion and work with the relevant authorities to ensure this treatment is available for eligible people living with early AD in the European Union as soon as possible.

Read Eisai press release

Michael Wonder

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Michael Wonder