LEQEMBI IQLIK (lecanemab-irmb)(at-home injection)

May 8, 2026: Eisai Co., Ltd. and Biogen Inc. (NASDAQ: BIIB) said the FDA extended by three months the review of their supplemental BLA for once-weekly lecanemab-irmb subcutaneous injection (LEQEMBI® IQLIK™) as a starting dose for treatment of early Alzheimer’s disease. The new PDUFA action date is August 24, 2026. The extension follows the FDA’s request for additional information that was deemed a major amendment; the companies stated the FDA has not raised concerns to date about approvability.

The release notes FDA approval of the subcutaneous maintenance dosing regimen on August 26, 2025, and states LEQEMBI is approved by more than 50 (53) regulatory authorities globally.

Other regulatory milestones cited: submission in Japan (November 2025) for a subcutaneous injectable formulation; acceptance in China (January 2026) of a BLA for the subcutaneous formulation; and inclusion of lecanemab IV on China’s “Commercial Insurance Innovative Drug List” (December 2025). Ongoing studies mentioned include Phase 3 AHEAD 3-45 (preclinical AD; ongoing since July 2020) and the DIAN-TU Tau NexGen study (ongoing since January 2022) with lecanemab as backbone anti-amyloid therapy.