FDA Approves LEQEMBI IQLIK Subcutaneous Injection for Maintenance Dosing in Early Alzheimer's Disease Treatment.

The FDA has approved Eisai and Biogen's LEQEMBI IQLIKTM, a once-weekly subcutaneous injection for maintenance dosing to treat early Alzheimer's disease. The approval is based on clinical trials showing that transitioning from intravenous treatment to the weekly autoinjector maintains clinical and biomarker benefits. The safety profile is similar to intravenous treatment, with less systemic reactions and no local or systemic injection-related adverse events. LEQEMBI IQLIKTM is indicated for patients with mild cognitive impairment or mild dementia stage of disease.

The U.S. Food and Drug Administration (FDA) has approved Eisai Co., Ltd. and Biogen Inc.'s LEQEMBI IQLIKTM, a once-weekly subcutaneous injection, for maintenance dosing to treat early Alzheimer's disease. The approval is based on clinical trials demonstrating that transitioning from intravenous (IV) treatment to the weekly autoinjector maintains clinical and biomarker benefits [1].

LEQEMBI IQLIKTM is indicated for patients with mild cognitive impairment (MCI) or mild dementia stage of disease, collectively referred to as early AD. After 18 months of LEQEMBI (lecanemab-irmb) IV treatment at 10 mg/kg every two weeks, patients may either continue IV infusions at 10 mg/kg once every four weeks or start the new weekly 360 mg subcutaneous injection using the LEQEMBI IQLIKTM autoinjector [1].

The clinical trials supporting the subcutaneous maintenance dosing approval were conducted as part of the Phase 3 Clarity AD open-label extension (OLE) trial. Data from these trials showed that transitioning to the weekly LEQEMBI IQLIKTM autoinjector after 18 months of the initiation dose (10 mg/kg IV every two weeks) maintains clinical and biomarker benefits comparable to continued IV dosing [1].

The safety profile of LEQEMBI IQLIKTM autoinjector was studied in over 600 patients at a range of doses as part of the Clarity AD OLE. Importantly, none of the 49 patients who received a weekly 360 mg subcutaneous maintenance dose experienced any local or systemic injection-related adverse events (AEs) [1]. Across all subcutaneous doses, the safety profile was similar to that of the IV maintenance treatment, with systemic reactions being much less common with subcutaneous dosing (less than 1%) compared to approximately 26% with IV infusions. Approximately 11% of patients experienced mild-to-moderate local reactions, which did not interfere with continued administration, and less than 1% had mild systemic symptoms such as headache, fever, or fatigue [1].

The approval of LEQEMBI IQLIKTM offers patients with early AD a new treatment option, allowing them to continue slowing the progression of the disease and prolonging the benefits of therapy with the goal of helping patients maintain who they are for longer [1]. Eisai is committed to ensuring that appropriate patients have access to LEQEMBI, offering several support programs to help patients and care partners navigate treatment and coverage [1].

References:
[1] https://www.nasdaq.com/press-release/fda-approves-leqembir-iqliktm-lecanemab-irmb-subcutaneous-injection-maintenance-2
[2] https://www.tradingview.com/news/reuters.com,2025-09-01:newsml_JCN102289a:0-fda-approves-leqembi-iqliktm-lecanemab-irmb-subcutaneous-injection-for-maintenance-dosing-for-the-treatment-of-early-alzheimer-s-disease/