LEQEMBI IQLIK accepted by FDA for review as a subcutaneous starting dose under Priority Review

The FDA has accepted Eisai's supplemental application for LEQEMBI IQLIK as a once-weekly subcutaneous starting dose and granted Priority Review with a PDUFA action date of May 24, 2026.

The U.S. Food and Drug Administration has accepted Eisai's supplemental biologics license application for LEQEMBI IQLIK, a subcutaneous autoinjector formulation of lecanemab, as a once-weekly starting dose for early Alzheimer's disease. The application has been granted Priority Review with a PDUFA action date of May 24, 2026. If approved, the proposed 500 mg weekly regimen (two 250 mg injections) could provide an at-home alternative to the current bi-weekly intravenous dosing for initiation and maintenance. Eisai and Biogen submitted data from sub-studies of the Phase 3 Clarity AD open‑label extension indicating that once-weekly 500 mg subcutaneous dosing achieved equivalent exposure to bi-weekly IV dosing and showed a similar safety profile. Key points: - The FDA accepted the supplemental biologics license application for LEQEMBI IQLIK as a weekly subcutaneous starting dose and granted Priority Review, with a PDUFA action date of May 24, 2026. - Data from Clarity AD open‑label extension sub-studies reported that once-weekly 500 mg subcutaneous administration achieved equivalent exposure to intravenous dosing every two weeks, with comparable clinical and biomarker findings. - The proposed regimen would use two 250 mg autoinjector injections; reported injection time is about 15 seconds per 250 mg injection and systemic injection or infusion‑related reactions were reported at under 2%. - LEQEMBI is reported as approved in 53 countries and regions, and the U.S. FDA previously approved a 360 mg weekly subcutaneous maintenance dosing regimen for LEQEMBI IQLIK in August 2025. - Safety information in the prescribing materials highlights risks such as amyloid-related imaging abnormalities (ARIA) and intracerebral hemorrhage (ICH), and includes monitoring and management recommendations. Summary: The FDA review will determine whether a weekly subcutaneous starting dose becomes an approved alternative to current intravenous dosing for early Alzheimer's disease. Undetermined at this time. The agency's action date for the Priority Review is May 24, 2026.