Eisai Initiates Rolling Submission for LEQEMBI Subcutaneous Autoinjector SBLA

Eisai has initiated a rolling submission for the Supplemental Biologics License Application (sBLA) for LEQEMBI IQLIK, a subcutaneous autoinjector for Alzheimer's disease treatment. LEQEMBI IQLIK has the potential to offer a weekly starting dose alternative to the current bi-weekly intravenous administration, expanding treatment options for patients. The SC formulation could reduce healthcare resources and streamline the overall treatment pathway.

Eisai Co., Ltd., in collaboration with BioArctic AB, has initiated a rolling submission of the Supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for LEQEMBI IQLIK (lecanemab-irmb) as a subcutaneous starting dose for the treatment of early Alzheimer's disease. This submission follows the FDA's Fast Track designation and the recent approval of LEQEMBI IQLIK for maintenance dosing in the US on August 29, 2025 [1].

The sBLA is based on the evaluation of subcutaneous (SC) lecanemab administration across various doses and sub-studies within the Phase 3 Clarity AD open-label extension. If approved, LEQEMBI IQLIK could offer a weekly starting dose alternative to the current bi-weekly intravenous (IV) administration. This would expand treatment options for patients and care partners, allowing for at-home injections from the initiation of treatment [2].

The SC formulation of LEQEMBI IQLIK has the potential to reduce healthcare resources associated with IV dosing, such as preparation for infusion and nurse monitoring, while streamlining the overall treatment pathway. The current injection time for each LEQEMBI IQLIK autoinjector is approximately 15 seconds [1].

LEQEMBI IQLIK is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ). It is approved in 48 countries and is under regulatory review in 10 countries. The antibody is the result of a strategic research alliance between BioArctic and Eisai, with BioArctic responsible for the development and Eisai for the clinical development, applications for market approval, and commercialization [1].

The collaboration between BioArctic and Eisai dates back to 2005, with significant milestones including the 2007 Development and Commercialization Agreement for the lecanemab antibody and the 2014 joint development and commercialization agreement with Biogen. BioArctic has no development costs for lecanemab in Alzheimer's disease and is entitled to payments in connection with regulatory approvals, sales milestones, and royalties on global sales [1].

References:

[1] https://www.morningstar.com/news/pr-newswire/20250902io64148/rolling-sbla-initiated-to-the-us-fda-for-leqembi-iqlik-lecanemab-irmb-as-a-subcutaneous-starting-dose-for-the-treatment-of-early-alzheimers-disease-under-fast-track-status
[2] https://media-us.eisai.com/2025-08-29-FDA-Approves-LEQEMBI-R-IQLIK-TM-lecanemab-irmb-Subcutaneous-Injection-for-Maintenance-Dosing-for-the-Treatment-of-Early-Alzheimers-Disease