# 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

_Saturday, June 27, 2026 at 12:05 AM EDT · science · Latest · Tier 2 — Notable_

![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 — Primary](https://mma.prnewswire.com/media/723010/Eisai_Logo_and_Biogen_Logo.jpg?p=facebook)

The U.S. Food and Drug Administration has accepted for review a supplemental biologics license application from Eisai for lecanemab-irmb. The product, branded LEQEMBI IQLIK, is proposed as a weekly subcutaneous starting dose for the treatment of early Alzheimer's disease.

The application was granted priority review. A prescription drug user fee act action date has been set for May 24, 2026.

Supporting data came from sub-studies within the phase 3 clarity AD open-label extension. Once-weekly administration of 500 milligrams via subcutaneous autoinjector achieved exposure equivalent to the current bi-weekly intravenous regimen. It also produced similar clinical and biomarker benefits.

The safety profile of subcutaneous administration was similar to intravenous use, with less than 2 percent incidence of systemic injection or infusion-related reactions. The formulation could reduce healthcare resources required for intravenous dosing, including infusion preparation and nurse monitoring. Eisai leads lecanemab development and regulatory submissions globally and co-commercializes the treatment with Biogen.

## Sources

- [PRNewswire](https://media-us.eisai.com/2026-01-25-FDA-Accepts-LEQEMBI-R-IQLIKTM-lecanemab-irmb-Supplemental-Biologics-License-Application-as-a-Subcutaneous-Starting-Dose-for-the-Treatment-of-Early-Alzheimers-Disease-under-Priority-Review)

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