FDA Approves LEQEMBI® For Alzheimer's IV Maintenance Dosing

Eisai, a company based in Tokyo, and Biogen from Cambridge, Massachusetts, shared news about their treatment for Alzheimer's disease. The Food Drug Administration approved LEQEMBI® as a new dosing method for Alzheimer's therapy. The FDA recently approved an IV infusion schedule for this early-stage Alzheimer's medicine that requires a base period of eighteen months followed by four-week treatments. Modelling simulations predict that transitioning to once every four weeks maintenance dosing after 18 months of once-every-two-week treatment will maintain the clinical and biomarker benefits of therapy. 

The approval decision relies on clinical trial findings showing that administrators can switch to monthly dosing without sacrificing treatment effectiveness for slowing Alzheimer’s progression. LEQEMBI works uniquely by clearing harmful substances in the brain that contribute to Alzheimer’s, continuing to protect neurons even after clearing the plaques often associated with the disease. 

The treatment is already available in several countries, including the U.S., Japan, South Korea, and Great Britain, and has received support for approval in Europe. Eisai is also working on another option: a weekly self-injection, which is currently under FDA review, with a decision expected later this year. Eisai is leading the development and regulatory process for LEQEMBI worldwide, while both Eisai and Biogen are handling sales and promotion.