FDA decision on monthly Leqembi dosing expected in January

Therapy currently administered every other week via infusion

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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The U.S. Food and Drug Administration (FDA) has agreed to review a supplemental application seeking authorization of once-monthly maintenance dosing for Leqembi (lecanemab), an approved treatment for early Alzheimer’s disease.

A decision from the agency is expected by Jan. 25, 2025, according to a press release from Eisai, which is codeveloping Leqembi alongside Biogen.

Leqembi last year became the first Alzheimer’s treatment to win full approval from the FDA. Under the current approval, Leqembi is administered via infusion into the bloodstream every other week.

If Eisai’s supplemental biologics license application is approved, patients taking Leqembi would initially receive the therapy every other week for a certain duration of time — exactly how long is still being discussed with the FDA. Then after that initiation period, patients could switch to infusions once monthly.

Eisai said it expects once-monthly infusions will be “less burdensome and easier for patients and care partners to continue long-term.”

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Leqembi designed to clear amyloid-beta protofibrils

Alzheimer’s is characterized by toxic clumps of the protein amyloid-beta in the brain, which are thought to drive the disease. Leqembi is designed to clear amyloid-beta protofibrils, an especially toxic form of this protein, thereby slowing disease progression. The therapy is indicated for use in Alzheimer’s patients with mild cognitive impairment or mild dementia who have evidence of amyloid buildup in the brain.

The FDA’s approval of Leqembi was based on data from clinical trials including the Phase 2b Study 201 (NCT01767311), the Phase 3 Clarity AD study (NCT03887455), and their open-label extension portions. Findings from these trials illustrated Leqembi treatment reduced amyloid buildup and slowed the decline in cognitive function scores.

Eisai’s supplemental application is based on modeling of data from these studies that indicate once-monthly maintenance dosing should maintain levels of the drug in the body that are sufficient to maintain continued clearance of amyloid-beta, which is expected to provide continual clinical benefit.

Advancing the once-monthly maintenance dosing is not the only way Leqembi’s developers are working to make the therapy more convenient for patients and their care partners.

Last month, Eisai initiated a rolling application to seek FDA approval for a weekly subcutaneous (under-the-skin) injection version of the therapy. Subcutaneous injections are much faster to administer than infusions, and whereas infusions need to be given under professional guidance, subcutaneous injections can often be administered at home by patients and caregivers who’ve had appropriate training.