LEQEMBI IQLIK is a first-of-its-kind anti-amyloid treatment worldwide, offering at-home dosing
for initiation and maintenance (approved in the U.S.)
U.S. launch of LEQEMBI IQLIK as an initiation dose planned for late August 2026
TOKYO and CAMBRIDGE, Mass., July 13, 2026 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB), announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for a once-weekly lecanemab-irmb subcutaneous injection (brand name: LEQEMBI IQLIK®) as an initiation dose for the treatment of early Alzheimer's disease.
LEQEMBI IQLIK is administered via an autoinjector, introducing a convenient alternative to intravenous (IV) dosing from the start of treatment. For initiation, the approved regimen is 500 mg given once weekly as two 250 mg injections, each delivered in approximately 15 seconds. LEQEMBI IQLIK may also be used for maintenance dosing at 360 mg once weekly after 18 months of IV or subcutaneous treatment. Throughout the entire treatment course – from initiation through maintenance – patients may receive LEQEMBI either as IV infusion or as subcutaneous (SC) injection with LEQEMBI IQLIK. Patients may also switch from IV to SC administration, or vice versa, providing greater convenience and flexibility in LEQEMBI administration.
LEQEMBI is indicated in the United States for adults with mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease, collectively referred to as early Alzheimer's disease. MCI due to AD is the earliest symptomatic stage of Alzheimer's disease and can appear with subtle symptoms such as forgetfulness, confusion, or feeling at a loss for words.
Clinical Data Supporting FDA Approval of Subcutaneous Initiation Dosing
The FDA approval of LEQEMBI IQLIK as an initiation dose is supported by a comprehensive clinical data package evaluating SC administration of lecanemab across multiple studies and a range of dosing regimens. Sub-studies within the Phase 3 Clarity AD long-term extension (LTE), following the 18-month core study in individuals with early Alzheimer's disease, showed:
Once-weekly subcutaneous administration achieved exposure equivalent to intravenous dosing, supporting similar clinical (efficacy) and biomarker (amyloid removal) benefits.
The rate of exposure-related adverse events such as ARIA-E with SC administration is expected to be comparable with IV administration. There was no increase in isolated ARIA-H (i.e., ARIA-H in patients who did not also experience ARIA-E) for LEQEMBI compared to placebo.
The overall safety profile of SC administration was generally similar to intravenous administration. Injection-related reactions were observed with subcutaneous LEQEMBI, most of which were localized, while systemic reactions were less frequently observed.