FDA Approves Monthly Maintenance Dosing for Eisai and Biogen’s Alzheimer’s Drug Leqembi

The FDA has approved a monthly maintenance dosing regimen for Leqembi (lecanemab-irmb) for the treatment of early Alzheimer's disease1 3.

Patients can transition to the new dosing schedule of 10 mg/kg once every four weeks after completing 18 months of the initial bi-weekly treatment1 9.

The approval is based on modeling data from Phase 2 and Phase 3 studies, predicting that the monthly dosing will maintain clinical and biomarker benefits of the therapy1 3.

Leqembi works by clearing amyloid-beta plaques and protofibrils from the brain, which are associated with Alzheimer's disease progression1 3.

The monthly maintenance dosing may be more convenient for patients and caregivers, potentially improving treatment adherence1 6.

Ongoing treatment with Leqembi is important as Alzheimer's disease progression does not stop after plaque clearance1 6.

Eisai and Biogen are also developing a subcutaneous autoinjector version of Leqembi for weekly maintenance dosing, which is currently under FDA review3 5.

Leqembi received traditional FDA approval in July 2023, following its initial accelerated approval in January 20237 8.

The drug has shown efficacy in slowing cognitive decline in early Alzheimer's disease patients, with a 27% reduction in clinical decline compared to placebo at 18 months1.

Leqembi's sales have been slower than initially projected, with challenges including reimbursement barriers and the need for increased provider awareness6.