FDA approves LEQEMBI IQLIK weekly injection to start early Alzheimer’s treatment
Approval follows AAIC 2026 data showing once-weekly 500 mg subcutaneous lecanemab matched intravenous exposure, with similar efficacy and safety signals and a planned U.S. launch in late August 2026.
The U.S. Food and Drug Administration approved Eisai and Biogen’s supplemental Biologics License Application for LEQEMBI IQLIK, a once-weekly subcutaneous lecanemab-irmb autoinjector, as an initiation dose for early Alzheimer’s disease. The decision allows LEQEMBI to be used in the United States from initiation through maintenance as either intravenous infusion or subcutaneous injection, with patients able to switch between routes. Supporting data presented by Eisai at the 2026 Alzheimer’s Association International Conference showed a 500 mg once-weekly subcutaneous initiation regimen achieved bioequivalent exposure to the approved IV initiation regimen of 10 mg/kg every two weeks, with an exposure ratio of 104% and a 90% confidence interval of 99.1% to 109%, alongside comparable efficacy, amyloid removal and safety signals. U.S. availability of initiation dosing is planned for late August 2026 through a specialty pharmacy.
- LEQEMBI IQLIK: Subcutaneous autoinjector form of lecanemab approved in the U.S. for maintenance and now initiation dosing
- ARIA: Amyloid-related imaging abnormalities, including brain swelling or bleeding seen on MRI with anti-amyloid therapies
- CDR-SB: Clinical Dementia Rating–Sum of Boxes, a standard measure of dementia severity and clinical decline