Eisai Expands Leqembi Subcutaneous Label, Accelerates Early U.S. Launch Progress for Alzheimer’s Disease
Eisai and Biogen have submitted a supplemental Biologics License Application (sBLA) to the U.S. FDA seeking to expand the label for Leqembi (lecanemab-irmb) subcutaneous autoinjector (SC-AI), branded as LEQEMBI IQLIK, to include a once-weekly starting dose for patients with early Alzheimer's disease1213.
LEQEMBI IQLIK received Fast Track status from the FDA, with a decision on the starting dose expansion expected in early Spring 2026128.
The subcutaneous formulation was previously approved in the U.S. for maintenance dosing after 18 months of intravenous (IV) Leqembi therapy, allowing for weekly at-home injections of 360 mg in patients with mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease4571112.
Eisai and Biogen launched LEQEMBI IQLIK in the U.S. for maintenance dosing on October 6, 2025, with companion support programs to aid patient and caregiver access3514.
If the expansion is approved, LEQEMBI IQLIK would be the first anti-amyloid Alzheimer's treatment to enable both therapy initiation and maintenance via at-home subcutaneous injections, offering an alternative to bi-weekly IV infusions and potentially reducing healthcare resource use while improving patient flexibility1213.
The SC autoinjector formulation is designed for rapid administration (about 15 seconds per injection) and aims to simplify ongoing care for early Alzheimer’s patients245.
The label for Leqembi IQLIK includes a Boxed Warning for Amyloid-Related Imaging Abnormalities (ARIA), emphasizing the need for monitoring during treatment311.
Sources:
1. https://www.neurologylive.com/view/eisai-submits-sbla-weekly-subcutaneous-lecanemab-starting-dose
2. https://www.prnewswire.com/news-releases/eisai-initiated-rolling-supplemental-biologics-license-application-to-the-us-fda-for-leqembi-iqlik-lecanemab-irmb-as-a-subcutaneous-starting-dose-for-the-treatment-of-early-alzheimers-disease-under-fast-track-status-302544347.html
3. https://practicalneurology.com/news/subcutaneous-lecanemab-approved-by-fda-for-maintenance-dosing-in-alzheimer-disease/2483177/
4. https://media-us.eisai.com/2025-08-29-FDA-Approves-LEQEMBI-R-IQLIK-TM-lecanemab-irmb-Subcutaneous-Injection-for-Maintenance-Dosing-for-the-Treatment-of-Early-Alzheimers-Disease
5. https://www.eisai.com/news/2025/news202571.html
7. https://www.eisai.com/news/2025/news202559.html
8. https://practicalneurology.com/news/fda-to-review-subcutaneous-lecanemab-treatment-as-a-starting-dose-for-early-alzheimers/2483259/
11. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761375s000lbl.pdf
12. https://www.alz.org/news/2025/fda-action-approving-leqembi-subcutaneous-maintenance-dosing
13. https://pharmaphorum.com/news/eisai-moves-swiftly-expand-subcutaneous-leqembi-label
14. https://www.prnewswire.com/news-releases/eisai-and-biogen-announce-us-availability-of-leqembi-iqlik-lecanemab-irmb-subcutaneous-injection-maintenance-dose-for-treatment-of-early-alzheimers-disease-302576192.html