Update on FDA Priority Review of LEQEMBI® IQLIK™ (lecanemab-irmb) Subcutaneous Injection as a Starting Dose for Early Alzheimer’s Disease
Biogen and Eisai announced that the FDA has extended the review period by three months for the supplemental Biologics License Application for LEQEMBI IQLIK, a once-weekly subcutaneous injection for initiating treatment of early Alzheimer's disease. The new PDUFA date is August 24, 2026. The FDA requested additional information, constituting a major…