Eisai's LEQEMBI IQLIK autoinjector approved by FDA for Alzheimer’s maintenance

Eisai Co., Ltd. announced on September 1, 2025, that the U.S. Food and Drug Administration (FDA) approved its Biologics License Application (BLA) for once-weekly lecanemab-irmb subcutaneous injection (LEQEMBI® IQLIK™). This approval is for maintenance dosing in early Alzheimer’s disease (AD). The new autoinjector, containing 360 mg/1.8 mL, allows for administration at home in approximately 15 seconds.

Effective August 29, 2025, the approval permits patients to switch to the subcutaneous autoinjector for maintenance after 18 months of initial intravenous (IV) treatment. This offers an alternative to continued IV infusions, aiming to prolong treatment benefits and slow disease progression. LEQEMBI IQLIK is expected to launch in the U.S. on October 6, 2025.

Eisai projects a minor impact on its consolidated financial forecast for FY2025 due to this approval, with no changes to the forecast announced on May 15, 2025. Eisai and Biogen will co-commercialize and co-promote the product.