FDA Approves LEQEMBI IQLIK(R) (lecanemab-irmb) Subcutaneous Injection as an Initiation Dose for Early Alzheimer’s Disease

TOKYO and CAMBRIDGE, Mass., July 15, 2026 – (JCN Newswire) – Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB), revealed that the U.S. Food and Drug Administration (FDA) has actually authorized an additional Biologics License Application(sBLA) for a once-weekly lecanemab-irmb subcutaneous injection (U.S. brand: LEQEMBI IQLIK ®) as an initiation dosage for the treatment of early Alzheimer’s illness.

LEQEMBI IQLIK is administered by means of an autoinjector, presenting a practical option to intravenous (IV) dosing from the start of treatment. For initiation, the accepted program is 500 mg offered as soon as weekly as 2 250mg injections, each provided in around 15 seconds. LEQEMBI IQLIK might likewise be utilized for upkeep dosing at 360 mg when weekly after 18 months of IV or subcutaneous treatment. Throughout the whole treatment course – from initiation through upkeep – clients might get LEQEMBI either as IV infusion oras subcutaneous (SC) injection with LEQEMBI IQLIK. Clients might likewise change from IV to SC administration, or vice versa, offering higher benefit and versatility in LEQEMBI administration.

LEQEMBI is suggested in the United States for grownups with moderate cognitive disability (MCI) or moderate dementia due to Alzheimer’s illness, jointly described as early Alzheimer’s illness. MCI due to advertisement is the earliest symptomatic phase of Alzheimer’s illness and can appear with subtle signs such as lapse of memory, confusion, or sensation at a loss for words.

Medical Data Supporting FDA Approval of Subcutaneous Initiation Dosing The FDA approval of LEQEMBI IQLIK as an initiation dosage is supported by a detailed medical information plan assessing SC administration of lecanemab throughout numerous research studies and a series of dosing routines. Sub-studies within the Phase 3 Clarity advertisement long-lasting extension (LTE), following the 18-month core research study in people with early Alzheimer’s illness, revealed:

* Once-weekly subcutaneous administration attained direct exposure comparable to intravenous dosing, supporting comparable medical (effectiveness) and biomarker (amyloid elimination) advantages.

* The rate of exposure-related negative occasions such as ARIA-E with SC administration is anticipated to becomparable with IV administration. There was no boost in separated ARIA-H (i.e., ARIA-H in clients who did not likewise experience ARIA-E) for LEQEMBI compared to placebo.

* The general security profile of SC administration was normally comparable to intravenous administration. Injection-related responses were observed with subcutaneous LEQEMBI, the majority of which were localized, while systemic responses were less often observed.

“The approval of LEQEMBI IQLIK for initiation dosing marks a brand-new period of Alzheimer’s treatments,” said Howard Fill it, MD, Co-Founder and Chief Science Officer Emeritus of the Alzheimer’s Drug Discovery Foundation(ADDF). “For the very first time, clients and their care partners have significant option in how anti-amyloid treatment is provided. As treatment techniques continue to broaden, developments in drug shipment will play acritical function in enhancing access to treatments, supporting the examination of possible mix treatments, and advancing an accuracy medication technique to Alzheimer’s care.”

Broadening Treatment Flexibility Across the Alzheimer’s Disease Care Pathway

The approval of LEQEMBI IQLIK as a subcutaneous initiation dosage offers clients and care partners with the only at-home administration choice throughout the Alzheimer’s illness treatment journey which might support gain access to and shipment of care throughout health care settings. Subcutaneous administration might:

* Reduce the problem of center sees for clients and care partners

* Reduce reliance on infusion and associated health care resources

* Decrease treatment preparation and administration time, and nursing tracking requirements

* Preserve infusion capability for clients who choose or need intravenous treatment

Insights from an autoinjector reputation research study showed that 94% of clients with early Alzheimer’s illness and their care partners, discovered the LEQEMBI IQLIK gadget simple to utilize, with high levels of fulfillment and self-confidence in utilizing it in an at-home setting. *

For more details: https://www.eisai.com/news/2026/pdf/enews202640pdf.pdf

Subject: Press release summary