Lecanemab Submissions Filed in Europe, Japan, and China

Following recent accelerated approval of Leqembi (lecanemab-imrt; Eisai, Tokyo, Japan; and Biogen, Cambridge, MA) by the Food and Drug Administration (FDA), the European Medicines Agency (EMA) has accepted a marketing authorization application for lecanemab for the early treatment of individuals diagnosed with AD with mild cognitive impairment or mild dementia stage of disease and confirmed presence of amyloid beta (Aβ) pathology. Earlier this month, Eisai announced that it had filed a supplemental Biologics License Application (sBLA) with the FDA, requesting that the FDA convert accelerated approval for lecanemab to traditional approval. In other announcements, Eisai reported that it had submitted a marketing authorization application to the Pharmaceuticals and Medical Devices Agency in Japan and had initiated submission of data for a Biologics Licensing Application to the National Medical Products Administration of China.

Lecanemab is a humanized immunoglobulin gamma 1 (lgG1) monoclonal antibody directed against aggregated soluble (“protofibril”) and insoluble forms of amyloid beta for the treatment of AD. The most common adverse reactions reported were infusion-related reactions, headache, cough, and diarrhea.