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Eisai Seeking FDA Approval for Leqembi as Monthly Maintenance Therapy for Alzheimer's Disease

NEW YORK – Eisai on Monday said it has submitted a supplemental biologics license application (BLA) to the US Food and Drug Administration seeking approval for Leqembi (lecanemab-irmb) as a maintenance treatment for Alzheimer's disease.

The FDA granted Tokyo-based Eisai, which codeveloped Leqembi with Biogen, accelerated approval for the monoclonal antibody treatment in January 2023 based on its ability to clear beta-amyloid plaque. That accelerated approval was converted to a full approval in July based on data demonstrating that Leqembi modestly slowed Alzheimer's progression. 

Since then, Eisai, which is leading development and regulatory submissions for Leqembi, and Cambridge, Massachusetts-based Biogen have said they are developing a lower dose version of Leqembi that can be given as maintenance treatment after initial clearance of beta-amyloid plaque.

In its latest application to the FDA, Eisai is seeking permission to market Leqembi to patients who have completed initial biweekly intravenous infusions of the treatment so they can continue to receive monthly infusions of lower doses of the drug to sustain beta-amyloid clearance. Eisai and the FDA are discussing the length of the biweekly treatment initiation phase.

The supplemental BLA contains modeling of observed data from Phase II and Phase III trials of Leqembi and open-label extensions of the two studies. 

Eisai previously said it would also seek regulatory approval for Leqembi as a weekly maintenance therapy that is subcutaneously administrated. The company had intended to initiate a rolling BLA in March under Leqembi's existing fast-track and breakthrough therapy designations, but the FDA told Eisai that it will need to seek fast-track designation specifically for the subcutaneous formulation. Eisai submitted a request for that designation last month.