Update on regulatory review of lecanemab for early Alzheimer’s disease in the European Union (July 2024)

Biogen

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 Alzheimer's disease (AD) (mild cognitive impairment due to 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 Biogen press release

Michael Wonder

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Michael Wonder