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FDA grants priority review to weekly at-home Alzheimer's injections
The FDA's Priority Review could allow at-home weekly subcutaneous dosing of LEQEMBI IQLIK, improving treatment convenience for early Alzheimer's patients, with approval decision by May 24, 2026.
- The FDA accepted Eisai Co., Ltd.'s supplemental BLA for LEQEMBI IQLIK and granted Priority Review, setting a PDUFA action date of May 24, 2026.
- Data from the Phase 3 Clarity Alzheimer's disease open‑label extension indicate Eisai Co., Ltd. and Biogen Inc. say the subcutaneous autoinjector 500 mg once‑weekly regimen achieves exposure comparable to every‑two‑weeks IV and allows at‑home administration.
- On imaging, ARIA‑E rates were reported as 13 with LEQEMBI versus 2 with placebo, and overall ARIA was 21 versus 9, with symptomatic ARIA in 3 and serious ARIA in 0.7.
- If approved, the autoinjector could offer a once-weekly 500 mg dose via two 250 mg injections, each taking approximately 15 seconds, complementing the 360 mg weekly SC maintenance approval .
- Regulatory activity continued with LEQEMBI , Eisai Co., Ltd. completing a rolling sBLA in November 2025, and guidance advising ApoE ε4 genotype testing plus MRI monitoring protocols.
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FDA Accepts LEQEMBI® IQLIKTM (lecanemab-irmb) Supplemental Biologics License Application as a Subcutaneous Starting Dose for the Treatment of Early Alzheimer's Disease under Priority Review
If approved, LEQEMBI IQLIK would be the first and only anti-amyloid treatment to offer at-home injection options for initiation and maintenance dosing for this progressive, relentless disease
Priority Review Granted for Weekly Subcutaneous Lecanemab Dosing in Early Alzheimer Disease | NeurologyLive - Clinical Neurology News and Neurology Expert Insights
If approved, lecanemab-irmb would provide an at-home subcutaneous injection option for both treatment initiation and maintenance dosing for patients with early-stage Alzheimer disease.
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