BRIEF—European submission for lecanemab complete

Eisai and Biogen have submitted for marketing authorization in Europe for their next-generation Alzheimer’s disease therapy lecanemab.

Recently  given the green light in the USA under the Accelerated Approval scheme, the anti-amyloid beta antibody is backed by  strong clinical evidence of a moderate benefit for people with early Alzheimer’s.

To be marketed in the USA as Leqembi, the product was tested in the Clarity AD trial, which met its primary endpoint and all key secondary endpoints.

The companies have also submitted for regular approval in the USA and China, and a submission in Japan is planned before the end of March 2023.