FDA approves subcutaneous injection of Leqembi for early Alzheimer's

The U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for Leqembi Iqlik® (lecanemab-irmb) subcutaneous injection as a starting dose for the treatment of early Alzheimer's disease. The US launch is planned for late August 2026.

Leqembi Iqlik, developed by BioArctic and partner Eisai, is an anti-amyloid treatment that can be administered at home via an autoinjector, offering a convenient alternative to intravenous (IV) infusion from the start of treatment. The approved starting regimen is 500 mg once weekly, administered as two injections. Leqembi Iqlik is already approved for maintenance dosing in the U.S. at 360 mg once weekly after completion of IV or subcutaneous treatment.

The drug is indicated for adults with mild cognitive impairment or mild dementia due to Alzheimer's disease. The FDA approval for subcutaneous initiation dosing is supported by clinical data showing that once-weekly subcutaneous administration achieved exposure equivalent to IV dosing, supporting similar clinical and biomarker benefits. The rate of exposure-related adverse events, such as ARIA-E (brain swelling), is expected to be comparable with IV administration.

"This approval represents another important step forward in the treatment of Alzheimer's disease," said Gunilla Osswald, CEO of BioArctic. "By providing a new administration option from the start of treatment, patients, caregivers and healthcare professionals gain greater flexibility in how therapy is delivered." The subcutaneous administration is expected to reduce the burden of clinic visits, decrease reliance on infusion-associated healthcare resources, and shorten treatment preparation and administration time. An autoinjector acceptability study indicated that 94% of patients and their care partners found the device easy to use at home.