Eisai today announced that the US Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for a once weekly lecanemab irmb subcutaneous injection (US brand name: Leqembi Iqlik) as a starting dose for the treatment of early Alzheimer's Disease (AD). The US launch is planned for late August 2026.

Leqembi Iqlik is a first of its kind anti-amyloid treatment worldwide, offering at-home dosing for initiation and maintenance. It is administered via an autoinjector, offering a convenient alternative to intravenous (IV) infusion from the start of treatment. For initiation, the approved regimen is 500 mg once weekly, delivered as 2 250 mg injections, each administered in approximately 15 seconds.

Leqembi Iqlik is already approved for maintenance dosing in the US at 360 mg once weekly, once 18 months of IV or subcutaneous treatment has been completed. Patients can now receive Leqembi either as an IV infusion or as a subcutaneous injection with Leqembi Iqlik throughout the entire treatment course—from initiation through maintenance and may switch between administration methods as needed, providing greater flexibility and convenience.

Leqembi is indicated in the US for the treatment of adults with Mild Cognitive Impairment (MCI) or mild dementia due to AD, collectively referred to as early AD. MCI due to Alzheimer's disease represents the earliest symptomatic stage of the disease and may be associated with subtle changes in memory, thinking, language, or daily functioning.

The FDA approval of Leqembi Iqlik for treatment initiation is supported by a comprehensive clinical data package evaluating SC administration of lecanemab across multiple studies and dosing regimens. Data from sub-studies within the phase 3 clarity AD Long-Term Extension (LTE), conducted following the 18-month core study in individuals with early AD, 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 (AEs) 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 localised, while systemic reactions were less frequently observed. 

Gunilla Osswald, CEO, BioArctic, said, "This approval represents another important step forward in the treatment of Alzheimer's Disease. By providing a new administration option from the start of treatment, patients, caregivers and healthcare professionals gain greater flexibility in how therapy is delivered. As the Alzheimer's Disease treatment landscape continues to advance, innovations that simplify access and support individualised care will be increasingly important. We are encouraged to see Eisai's diligent work to meet the diverse needs of people living with this difficult disease."

The approval of Leqembi Iqlik as a subcutaneous starting dose provides patients and care partners with the only at-home administration option throughout the AD treatment journey which could support access and delivery of care across healthcare settings. Subcutaneous administration may reduce the burden of clinic visits for patients and care partners; reduce reliance on infusion and associated healthcare resources; decrease treatment preparation and administration time, and nursing monitoring requirements; preserve infusion capacity for patients who prefer or require intravenous therapy.

Insights from an autoinjector acceptability study indicated that 94 percent of patients with early AD and their care partners found the Leqembi Iqlik device easy to use, with high levels of satisfaction and confidence in using it in an at-home setting.