Eisai and Biogen Announce FDA Approval of LEQEMB® (Lecanemab) Subcutaneous Autoinjector (IQLIKTM) for Maintenance Treatment of Early Alzheimer's Disease (AD); Set to Launch in the U.S. on October 6, 2025.
Lecanemab IQLIKTMIt is the first automatic injection therapy for AD that can be completed at home, developed by Eisai. This subcutaneous automatic injector (SC-AI) contains a dose of 360 mg/1.8 mL (200 mg/mL) and can deliver the medication in approximately 15 seconds.
Lecanemab IQLIKTMFor maintenance treatment of patients with mild cognitive impairment and mild dementia in the early stages of Alzheimer's disease (AD).
Lecanemab is a monoclonal antibody targeting amyloid-beta (Aβ) that continuously clears neurotoxic protofibrils, namely Aβ plaques, and slows disease progression.
The newly approved formulation, based on Clarity AD and its open-label extension data, demonstrated clinical and biomarker benefits comparable to intravenous administration, with a favorable safety profile.
Compared with intravenous infusion, subcutaneous injection significantly reduces the incidence of systemic reactions (<1% vs. 26%) and is convenient for patients and their caregivers to complete treatment at home, reducing the frequency of medical visits.
In terms of dosage, after receiving 10 mg/kg intravenous (IV) infusions of lecanemab every two weeks for 18 months, patients may continue with 10 mg/kg IV infusions every four weeks or switch to weekly subcutaneous injections of 360 mg using lecanemab IQLIKTM.
Subcutaneous injection will reduce the number of patient visits to the hospital, lower care costs, improve treatment adherence, and save costs for the healthcare system.
Eisai Co., Ltd. leads the global development and registration application of lecanemab, while the product is co-commercialized and promoted by Eisai Co., Ltd. and Biogen Inc. Among them, Eisai Co., Ltd. has the final decision-making authority.
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