Eisai Completes FDA Submission For LEQEMBI Weekly Autoinjector, Paving The Way For At-Home Alzheimer’s Treatment

Eisai and Biogen announced the completion of Eisai’s rolling submission of a supplemental Biologics License Application (sBLA) to the U.S. FDA for LEQEMBI IQLIK, a subcutaneous autoinjector version of lecanemab for weekly dosing in early Alzheimer’s disease. The application, submitted under Fast Track status, aims to introduce an at-home alternative to the current bi-weekly intravenous (IV) regimen used for patients in the mild cognitive impairment and mild dementia stages of AD.

The submission is supported by data from subcutaneous dosing studies within the Phase 3 Clarity AD open-label extension. These results show that a once-weekly 500 mg subcutaneous dose achieves drug exposure equivalent to the bi-weekly IV infusion while maintaining similar clinical efficacy, biomarker responses, and safety outcomes. Notably, subcutaneous treatment showed fewer than 2% systemic injection or infusion-related reactions, reinforcing its potential for convenient home administration.

If approved, LEQEMBI IQLIK would allow patients to receive both initiation and maintenance treatment via autoinjector, reducing reliance on infusion centers and healthcare resources. LEQEMBI, which targets both amyloid protofibrils and plaque, is currently approved in 51 countries and under review in nine more. Eisai leads global development and regulatory efforts, with both companies sharing commercialization.