FDA Approves Subcutaneous Leqembi Injection for Early Alzheimer's Disease
The US Food and Drug Administration has approved a once-weekly subcutaneous injection of Leqembi Iqlik® (lecanemab-irmb) as a starting dose for treating early Alzheimer's disease.
The US Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for Leqembi Iqlik® (lecanemab-irmb), a once-weekly subcutaneous injection for the treatment of early Alzheimer's disease. Developed by BioArctic AB's partner Eisai, the drug is slated for a US launch in late August 2026.
Leqembi Iqlik is designed to be administered under the skin using an autoinjector, offering a convenient option for initiation and maintenance dosing. This approval marks the introduction of the first anti-amyloid treatment globally that allows for at-home initiation and maintenance.
BioArctic AB, based in Stockholm, Sweden, is a biopharmaceutical company focused on research and development of therapies for neurological and inflammatory diseases. Eisai, the company's partner, will be responsible for the commercialization of Leqembi in the United States.
The subcutaneous formulation is expected to improve patient access and adherence to treatment. Alzheimer's disease affects millions worldwide, and the development of new therapeutic options like Leqembi is crucial in managing the progression of the disease and improving patient outcomes. This approval provides a new option for patients diagnosed with early Alzheimer's disease.