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FDA Accepts Eisai's Supplemental BLA for Leqembi as Monthly Maintenance Therapy

NEW YORK – The US Food and Drug Administration has accepted Eisai's supplemental biologics license application (BLA) seeking approval for the Alzheimer's disease drug Leqembi (lecanemab) as a maintenance treatment.

The FDA expects to issue a decision on the application by Jan. 25, 2025, the company announced this weekend.

Eisai, which codeveloped Leqembi with Biogen, received FDA approval for the drug last year as a treatment to slow disease progression in patients with early Alzheimer's by targeting beta-amyloid plaque. It's now seeking permission to market a version that patients would receive on a monthly basis after completing initial biweekly intravenous infusions. The idea is that a maintenance treatment would sustain a reduction in protofibrils, which the company said are a particularly toxic form of beta-amyloid that can cause neuronal injury.

Tokyo-based Eisai said it is discussing the length of the biweekly treatment initiation phase with the FDA.

The supplemental BLA contains modeled observational data from Phase II and Phase III clinical trials of Leqembi and their open-label extensions. In these studies, investigators observed that continued Leqembi treatment beyond an 18-month period prolonged clinical benefit.

Separately, Eisai has initiated a rolling submission of a BLA that is seeking approval for a subcutaneous version of Leqembi that could be given as a weekly maintenance treatment, and which the company has said would be more convenient and less burdensome than the monthly intravenous infusions.

The FDA is also in the midst of reviewing a BLA on another drug in this class from Eli Lilly, donanemab. An advisory committee to the FDA recently voted in support of donanemab's risk-benefit profile. Lilly doesn't expect donanemab will need maintenance dosing and has said that patients would be able to stop treatment after reaching a certain threshold of beta-amyloid reduction.