BRIEF—EMA accepts Eisai's marketing application for Leqembi

The European Medicines Agency (EMA) has accepted a marketing authorization application (MAA) for Japanese drugmaker Eisai and US biotech Biogen’s lecanemab for the treatment of early Alzheimer’s disease (mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD dementia) with confirmed amyloid pathology, for review following a standard timeline.

In the USA, lecanemab – under the brand name Leqembi - was granted accelerated approval as a treatment for AD by the US Food and Drug Administration (FDA) on January 6, 2023.

On the same day, Eisai submitted a Supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway based on the results from the Phase III Clarity AD confirmatory study.

In Japan, Eisai submitted a marketing authorization application to the Pharmaceuticals and Medical Devices Agency (PMDA) on January 16, 2023.

In China, Eisai has initiated submission of data for a BLA to the National Medical Products Administration (NMPA) of China in December 2022.

Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.