The US Food and Drug Administration (FDA) has approved Leqembi IQLIK, a weekly subcutaneous (under-the-skin) autoinjector version of the Alzheimer’s drug Lecanemab (Lecanemab-irmb), developed by Eisai and Biogen. This marks the first Alzheimer’s maintenance therapy that patients can administer at home.

Leqembi IQLIK, delivering a 360 mg dose within 15 seconds, will be available starting 6 October, 2025, at a list price of USD 19,500 annually for a pack of pre-filled autoinjectors. The new format is approved for patients with early Alzheimer’s disease—specifically mild cognitive impairment or mild dementia—who have completed 18 months of intravenous (IV) infusions. Patients may either continue IV infusions at 10 mg/kg once every four weeks or start the new weekly 360 mg subcutaneous injection using the LEQEMBI IQLIK autoinjector.

The FDA approval was supported by data from the Phase –III Clarity AD extension trial showing that switching to subcutaneous dosing maintains both clinical efficacy and biomarker benefits compared to continued IV delivery.

The safety profile was comparable and, in some respects, improved: fewer than one per cent of patients experienced systemic reactions with the injection versus approximately 26 per cent during IV infusions. Local injection-site reactions occurred in about 11 per cent of patients and did not disrupt treatment. The rate of Amyloid-Related Imaging Abnormalities (ARIA) remained similar to IV-treated patients, and were observed during early treatment phases.

To support access to LEQEMBI for certain patients who need help paying for their medicines, Eisai's Patient Assistance Programme (PAP) will provide LEQEMBI and LEQEMBI IQLIK at no cost for eligible uninsured and underinsured patients, including Medicare beneficiaries, who meet financial need and other programme criteria.