Eisai Secures FDA Approval for Leqembi Autoinjector for Maintenance Dosing in Alzheimer’s Patients

On August 30, 2025, Eisai and co-developer Biogen received FDA approval for the LEQEMBI IQLIK (lecanemab-irmb) subcutaneous autoinjector for maintenance dosing in early Alzheimer's disease134.

The LEQEMBI IQLIK autoinjector contains 360 mg/1.8 mL (200 mg/mL) of lecanemab and delivers the medication in about 15 seconds12.

This new formulation enables weekly at-home subcutaneous injections as maintenance therapy for patients who have completed the initial 18-month IV infusion phase, offering an alternative to less frequent IV infusions at a clinic124.

Patients with mild cognitive impairment or mild dementia due to Alzheimer's disease can transition from biweekly IV infusions to this weekly at-home injection after the loading phase124.

The at-home injectable addresses a major convenience challenge by reducing the need for hospital or infusion center visits, easing the treatment burden on patients and their caregivers2.

LEQEMBI was previously approved in the U.S. and other regions as an IV infusion; this approval marks the first time an Alzheimer’s therapy can be maintained via autoinjector at home12.

Based on clinical evidence from the Phase 3 CLARITY-AD trial, continued maintenance dosing with subcutaneous lecanemab showed sustained clinical and biomarker benefits2.

LEQEMBI IQLIK autoinjector will be launched in the U.S. on October 6, 20254.

Sources:

1. https://www.eisai.com/news/2025/news202559.html

2. https://www.brightfocus.org/news/fda-approves-at-home-injectable-leqembi-for-alzheimers/

3. https://media-us.eisai.com/pressreleases?item=122972

4. https://www.thepharmaletter.com/biotechnology/fda-green-light-for-leqembi-subcutaneous-formulation