FDA Extends Review of Application for Leqembi IQLIK as Starting Dose for Those with Early Alzheimer’s
KEY TAKEAWAYS
- The FDA extended the review of the sBLA for Leqembi IQLIK after Eisai and Biogen submitted additional information.
- The updated target action date is August 24, 2026.
- The pending application seeks approval of a 500 mg once-weekly subcutaneous starting-dose regimen for patients with early Alzheimer disease.
The Food and Drug Administration (FDA) has extended its review of Eisai and Biogen’s supplemental biologics license application (sBLA) for Leqembi IQLIK (lecanemab-irmb; Eisai, Tokyo, Japan; Biogen, Cambridge, MA) as a once-weekly subcutaneous starting dose for patients with early Alzheimer disease (AD). The agency moved the anticipated decision date from May 24, 2026, to August 24, 2026. According to statements issued by Eisai and Biogen, the FDA requested additional information considered a “major amendment” to the application, resulting in a standard 3-month extension of the review timeline.
Shift Toward At-Home Administration Faces Temporary Delay
Leqembi IQLIK was approved by the FDA in August 2025 as a weekly subcutaneous maintenance therapy following 18 months of intravenous Leqembi treatment. Intravenous Leqembi was originally approved by the FDA in July 2023 as a treatment for patients with early AD, including those with mild cognitive impairment or mild dementia stage disease with confirmed amyloid pathology.
The pending sBLA seeks approval for Leqembi IQLIK to be used beginning at treatment initiation. The proposed regimen consists of a 500 mg once-weekly subcutaneous dose administered as two 250 mg injections via autoinjector.
If approved, the formulation could enable fully subcutaneous administration at home, potentially reducing infusion-center utilization and expanding treatment flexibility for patients and caregivers.
Clinical and Safety Considerations
Eisai and Biogen stated that the FDA has not raised concerns to date regarding the approvability of the application. Available pharmacokinetic and clinical data suggest that weekly subcutaneous dosing may provide exposure and biomarker effects comparable to intravenous administration.
Leqembi continues to carry a boxed warning for amyloid-related imaging abnormalities (ARIA), including ARIA-E (edema) and ARIA-H (microhemorrhage and superficial siderosis), which may be serious or, in rare cases, fatal. MRI monitoring recommendations remain part of the prescribing information.
Sources
- Eisai Co., Ltd. Update on FDA Priority Review of LEQEMBI® IQLIK™ (lecanemab-irmb) Subcutaneous Injection as a Starting Dose for Early Alzheimer’s Disease. News release. May 8, 2026. Accessed May 14, 2026. https://media-us.eisai.com/2026-05-08-Update-on-FDA-Priority-Review-of-LEQEMBI-R-IQLIK-TM-lecanemab-irmb-Subcutaneous-Injection-as-a-Starting-Dose-for-Early-Alzheimers-Disease
- Biogen. FDA Accepts LEQEMBI® IQLIK™ (lecanemab-irmb) Supplemental Biologics License Application for Subcutaneous Maintenance Dosing and Initiation in Early Alzheimer’s Disease. News release. Accessed May 14, 2026. https://investors.biogen.com/news-releases/news-release-details/fda-accepts-leqembir-iqliktm-lecanemab-irmb-supplemental