DA Approves LEQEMBI IQLIK Subcutaneous Injection for Early Alzheimer’s Disease Treatment
Tuesday, July 14, 2026
Eisai and Biogen have received approval from the US Food and Drug Administration (FDA) for a supplemental Biologics License Application (sBLA) for LEQEMBI IQLIK (lecanemab-irmb), a once-weekly subcutaneous injection for the initiation treatment of early Alzheimer’s disease.
LEQEMBI IQLIK is administered using an autoinjector, providing an alternative to intravenous (IV) infusion from the start of treatment. The approved initiation regimen consists of 500 mg once weekly, delivered as two 250 mg injections, each taking around 15 seconds. After 18 months of treatment, patients may continue with a 360 mg weekly maintenance dose using LEQEMBI IQLIK or receive maintenance treatment through IV infusion.
Patients can receive LEQEMBI either by intravenous infusion or subcutaneous injection throughout the full treatment course. They may also switch between the two administration methods, offering greater flexibility based on clinical needs and patient preference.
In the US, LEQEMBI is approved for adults with mild cognitive impairment or mild dementia caused by Alzheimer’s disease, collectively referred to as early Alzheimer’s disease.
The FDA approval is supported by clinical data from multiple studies, including sub-studies of the Phase 3 Clarity AD long-term extension trial. Results showed that once-weekly subcutaneous administration achieved drug exposure comparable to intravenous dosing, supporting similar clinical benefits and amyloid plaque reduction.
The studies also indicated that the rate of exposure-related adverse events, including amyloid-related imaging abnormalities with oedema (ARIA-E), is expected to be similar to IV treatment. No increase in isolated ARIA-H events was observed compared with placebo, and the overall safety profile of the subcutaneous formulation was generally consistent with intravenous administration. Injection-related reactions were mostly mild and localised, while systemic reactions occurred less frequently.
The approval introduces an at-home treatment option that may reduce the need for clinic visits, lower reliance on infusion services, shorten treatment administration time and help preserve infusion capacity for patients who require or prefer intravenous therapy.
An autoinjector usability study involving patients with early Alzheimer’s disease and their care partners found that 94% considered the LEQEMBI IQLIK device easy to use and expressed confidence in using it at home.
Eisai and Biogen will also continue to support eligible patients through the LEQEMBI Companion programme and Eisai’s Patient Assistance Programme, which provide help with insurance, financial assistance and access to treatment.
LEQEMBI IQLIK for initiation dosing is expected to become available in the United States in late August 2026 through specialty pharmacies. Eisai leads the global development and regulatory activities for lecanemab, while Eisai and Biogen jointly commercialise and promote the therapy.
