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FDA Accepts Eisai's BLA for Subcutaneous Leqembi Maintenance Dosing

NEW YORK – The US Food and Drug Administration has accepted Eisai's biologics license application (BLA) seeking approval for a subcutaneous form of Leqembi (lecanemab) that can be dosed as maintenance treatment for early Alzheimer's disease.

Eisai announced with its Leqembi codevelopment partner Biogen on Monday that they expect the FDA to issue a decision on the Leqembi subcutaneous autoinjector by Aug. 31. Eisai leads Leqembi's development and regulatory submissions, while it commercializes and promotes the product in partnership with Cambridge, Massachusetts-based Biogen.

If approved, Leqembi would be the only anti-amyloid drug on the market available in a subcutaneous formulation, which patients can administer at home in 15 seconds, according to Eisai and Biogen.

The two beta-amyloid-targeting drugs currently on the market, Eisai and Biogen's Leqembi and Eli Lilly's Kisunla (donanemab), are both administered with intravenous infusions. Kisunla is administered monthly until patients' levels of beta-amyloid plaque drop below a certain threshold, at which point they can stop treatment.

Leqembi, on the other hand, is administered biweekly. In submitting this BLA, which is based on data from the open-label extension portion of the Phase III CLARITY AD trial and modeling of observational data, Eisai is proposing that patients could switch to weekly maintenance dosing with the subcutaneous formulation after an initial regimen of biweekly infusions.

Separately, Tokyo-based Eisai last year submitted a supplemental BLA seeking approval for a lower dose of Leqembi intravenous infusions as a maintenance treatment, which would be taken monthly after the initial set of biweekly infusions. The FDA expects to issue a decision on that application by Jan. 25.