Biogen and Eisai said they believe that EC's requests can be addressed with existing information, and that no new safety signals have been identified for Leqembi. The U.S. Food and Drug Administration in 2023 approved Leqembi, which is also approved in the U.K., Japan, China and several other countries.

The Japanese and American based pharma companies announced a win for their Alzheimer’s treatment, which has faced some negative backlash over the last year.

Eisai (ESAIY) and Biogen (BIIB) announced that the U.S. Food and Drug Administration, FDA, has approved the Supplemental Biologics License

Biogen and Eisai have won Food and Drug Administration approval of an intravenous maintenance dosing of their Leqembi drug for early Alzheimer's disease. The companies late Sunday said the FDA approved the maintenance dosing of once every four weeks after 18 months of the initiation phase of once every two weeks.

The FDA has approved Eisai (OTCPK:ESALF) and Biogen's (NASDAQ:BIIB) supplemental application for four-week maintenance dosing of their Alzheimer's drug Leqembi. The agency approved Leqembi to be dosed every four weeks via IV as a maintenance therapy.