Eisai Submits Supplemental Biologics License Application to FDA for Traditional Approval of LEQEMBI™ (lecanemab-irmb) for the ...
Submission for traditional approval follows FDA accelerated approval of LEQEMBI on the same day, and is based on data from the confirmatory Phase 3 Clarity AD clinical trial TOKYO and CAMBRIDGE, Mass., Jan. 6, 2023 /PRNewswire/ -- Eisai Co., Ltd. ( …