FDA approves new Alzheimer’s treatment regimen

Patients and care partners may find once every four weeks maintenance dosing easier

The US Food and Drug Administration (FDA) has approved a new dosing regimen for LEQEMBI, a treatment for early Alzheimer’s disease, according to Eisai and Biogen Inc.

The maintenance dosing will now be administered once every four weeks, a change that may make it easier for patients and their care partners to continue treatment.

Early Alzheimer’s disease includes mild cognitive impairment (MCI) or mild dementia. Previously, LEQEMBI was given every two weeks. The transition to a once every four weeks maintenance dosing can be considered after 18 months of the initial phase.

Based on data from the phase 2 Study 201 and the Clarity AD study, as well as their long-term extensions, it was predicted that the new regimen would maintain the clinical and biomarker benefits. Dr Ivan Cheung, Chairman of Eisai Inc., remarked: “This regimen offers a balance between efficacy and convenience for patients.”

Continuous treatment with LEQEMBI is essential, even after amyloid-beta plaque clearance from the brain. This treatment targets highly toxic protofibrils that contribute to neuronal injury. Dr Samantha Budd Haeberlein, Head of Neurodegeneration Development at Biogen, explained: “Ongoing treatment can slow disease progression and prolong the benefits of therapy.”

LEQEMBI is currently approved in multiple countries, including the U.S., Japan, and Great Britain, among others. Eisai has also submitted applications for approval in 17 other regions.

The FDA has accepted Eisai’s Supplemental Biologics License Application for LEQEMBI’s subcutaneous autoinjector for weekly maintenance dosing, with a decision expected by August 31, 2025.

Dr Cheung concluded: “We are committed to providing effective treatment options for patients with Alzheimer’s disease.”