Eisai has completed the rolling submission of its Supplemental Biologics License Application (sBLA) to the US Food and Drug Administration for LEQEMBI IQLIK, a once-weekly subcutaneous autoinjector formulation of lecanemab-irmb (LEQEMBI), following the FDA’s Fast Track designation.

LEQEMBI is approved for the treatment of early Alzheimer’s disease, including Mild Cognitive Impairment and mild dementia. Once the sBLA is accepted, the FDA will assign a Prescription Drug User Fee Act (PDUFA) action date.

The application is supported by data from subcutaneous dosing studies and Phase 3 Clarity AD open-label extension analyses, showing that a 500 mg weekly SC dose delivered equivalent drug exposure, clinical outcomes, and biomarker benefits to the currently approved bi-weekly intravenous (IV) dosing. The safety profile was comparable, with less than 2% incidence of systemic injection or infusion reactions.

If approved, LEQEMBI IQLIK would offer patients a once-weekly, at-home SC option—administered via two 250 mg autoinjectors taking about 15 seconds each—potentially reducing reliance on infusion centers and associated healthcare resources.

LEQEMBI is approved in 51 countries and under review in nine others. Eisai leads global development and regulatory strategy, while co-commercializing the therapy with Biogen.