FDA Approves Leqembi Injection for Early Alzheimer's Starting Dose

The U.S. Food and Drug Administration (FDA) has approved Leqembi Iqlik® (lecanemab-irmb) subcutaneous injection, a weekly dosage form, as a new option for initiating treatment of early Alzheimer's disease. BioArctic AB's partner, Eisai, anticipates launching the subcutaneous formulation in the U.S. in late August 2026.

Leqembi Iqlik offers patients an at-home dosing alternative, complementing the previously approved Leqembi intravenous infusion. The new injection format aims to reduce the burden of clinic visits for patients and caregivers, and alleviate pressure on healthcare resources. The drug is administered via an autoinjector once per week, and patients can switch between administration methods as needed throughout their treatment course.

The approval is supported by clinical trial data demonstrating comparable efficacy and safety between the subcutaneous administration of lecanemab and the intravenous route. The treatment is indicated for adult patients with mild cognitive impairment or mild dementia due to Alzheimer's disease. BioArctic and Eisai developed the medication through a strategic research alliance.

While a subcutaneous formulation has previously been approved for maintenance dosing in the U.S., this new approval allows for the subcutaneous administration to be used from the initiation of treatment. This change is expected to improve treatment adherence and accessibility for patients, offering greater flexibility and personalized care.