BRIEF—Lecanemab granted priority review in Japan

The Japanese Ministry of Health, Labor and Welfare (MHLW) has designated Eisai’s application for manufacturing and marketing approval for lecanemab, an anti-amyloid-β (Aβ) protofibril antibody for priority review, for the treatment of Alzheimer’s disease (AD).

Priority Review in Japan is granted to new medicines recognized as having high medical utility for serious diseases, and once designated for Priority Review, the target total review period is shortened.

In Japan, Eisai submitted the manufacturing and marketing approval for lecanemab to the Pharmaceuticals and Medical Devices Agency (PMDA) on January 16, 2023. This application is based on the results of the Phase III Clarity AD study and the Phase IIb clinical study (Study 201), which demonstrated that lecanemab treatment showed a reduction of clinical decline in early AD.

In the USA, lecanemab was granted accelerated approval as a treatment for Alzheimer’s disease by the Food and Drug Administration (FDA) on January 6, 2023, under the trade name Leqembi.

On the same day, Eisai submitted a Supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway