Updated: FDA Approves Leqembi Autoinjector for Maintenance Dosing in Alzheimer’s

The FDA has approved a subcutaneous version of the Alzheimer’s therapy Leqembi. Called Leqembi IQLIK (lecanemab-irmb), it is a once-weekly subcutaneous autoinjector that is indicated for maintenance dosing (after 18 months of receiving Leqembi IV every two weeks) to treat Alzheimer’s disease (AD) in patients with mild cognitive impairment or mild dementia.

“This shift to subcutaneous maintenance dosing is a crucial step toward making Leqembi more accessible for patients, similar to how diabetes and GLP-1 medications are delivered, and represents the first step towards the day when patients can bypass infusions altogether,” Howard Fillit, M.D., co-founder and chief science officer of the Alzheimer’s Drug Discovery Foundation, said in a news release.

Developed by Eisai and comarketed by Eisai and Biogen, Leqembi IQLIK will launch on Oct. 6, 2025, with a wholesale acquisition cost of $375 per autoinjector (or $19,500 annually). Eisai officials point out in a statement on pricing that patients with Medicare Part D are subject to an annual out-of-pocket cap of $2,000, and some patients, depending on their plan, may have a copay that is less than the annual cap.

A spokesperson with Eisai said the cost reflects the approximate cost for a patient without insurance coverage. "Eisai’s pricing reflects the balance between enabling broad patient access, supporting long-term sustainability of the healthcare system, and recognizing the demonstrated societal value of subcutaneous administration," the spokesperson said.

In an analysis sponsored by Eisai and published in July 2025, Leqembi IQLIK could result in per-patient savings of between $72,891 and $80,925 over four years compared with IV Leqembi. These savings are driven by reduced treatment costs attributed to a more efficient fixed-dose autoinjector delivery, lower administrative costs, and reduced time spent by healthcare providers, patients and care partners.

Leqembi IV, approved by the FDA in July 2023, has a list price of $258.64 for a 200 mg vial and $646.61 for a 500 mg vial as of April 2025. The wholesale acquisition cost is approximately $13,316 for Leqembi IV maintenance therapy, the spokesperson said. Because Leqembi has weight-based dosing, the price per patient will vary.

Eisai also offers for commercially insured patients a $0 copay program, with a $10,000 annual limit, as well as a temporary supply program and a patient assistance program.

“The expectation with subcutaneous delivery of Alzheimer’s treatment is that patients and care partners find it easier, simpler and more convenient to use, and that it reduces the need to travel for hospital or infusion center visits, compared to intravenous infusion,” Maria C. Carrillo, Ph.D., Alzheimer’s Association chief science officer and medical affairs lead, said in a news release. “The result is that more people will continue taking their medicine and experiencing treatment benefits.”

Approval Data

The approval of Leqembi IQLIK was based on the subcutaneous sub-studies of the phase 3 Clarity AD open-label extension (OLE) trial in patients with early Alzheimer’s disease. The trial, which evaluated a range of subcutaneous doses, showed that transitioning to the weekly autoinjector after 18 months maintains clinical and biomarker benefits comparable with continued IV dosing.

Across all subcutaneous doses, the safety profile was similar to that of the IV maintenance treatment with one key difference: systemic reactions were much less common with subcutaneous dosing: less than 1% compared with approximately 26% with IV infusions.

Approximately 11% of patients experienced mild-to-moderate local reactions (such as redness, swelling or itching at the injection site), which did not interfere with continued administration, and less than 1% had mild systemic symptoms such as headache, fever or fatigue.

Rates of amyloid-related imaging abnormalities (ARIA), which appear as brain edema, in patients who received the subcutaneous Leqembi were similar to ARIA rates reported in patients who continued with the IV dose and are similar to the background rates of ARIA in patients without treatment. ARIA can be serious and life-threatening.

Alzheimer’s is a progressive and incurable neurodegenerative disorder that affects more than 7.2 million Americans over the age of 65. Although the root cause is unknown, it is characterized by the buildup of toxic amyloid-beta plaque and protofibrils. Leqembi works by continuously clearing both plaque and protofibrils, therefore slowing cognitive decline.

Supplemental Application

Eisai has initiated a rolling supplemental biologics license application for Leqembi IQLIK as a weekly subcutaneous starting dose. The application is based on data from the phase 3 Clarity AD open-label expansion study, following the 18-month core study of people with early Alzheimer's disease.

If approved, this could be alternative to the bi-weekly IV dosing.

This story was updated to include information about the sBLA.