Eisai Co., Ltd. and Biogen Inc. announced that the U.S. Food and Drug Administration has extended the priority review by three months for the supplemental biologics license application for a once-weekly LEQEMBI IQLIK (lecanemab-irmb) subcutaneous injection as a starting dose, moving the PDUFA action date to 24 August 2026.
The FDA requested additional information that the agencies say constituted a major amendment and extended the review to allow sufficient time for full evaluation; the agency has not raised any approvability concerns to date.
The companies note that subcutaneous maintenance dosing with LEQEMBI IQLIK received U.S. approval on 26 August 2025, and the firms contend the comprehensive clinical data package supports potential use of the subcutaneous starting dose following maintenance approval.
LEQEMBI has been approved in 53 countries and regions, the companies said. The announcement reiterates important safety information, including the risk of amyloid-related imaging abnormalities and intracerebral hemorrhage, a higher ARIA risk in ApoE ε4 homozygotes, and the recommendation to perform ApoE ε4 testing prior to initiation.
