Eisai Initiated Rolling Supplemental Biologics License Application to the U.S. FDA for LEQEMBI® IQLIK™ (lecanemab-irmb) as a Subcutaneous Starting Dose for the Treatment of Early Alzheimer's Disease Under Fast Track Status
1. Eisai and Biogen submitted sBLA for LEQEMBI IQLIK to FDA. 2. LEQEMBI IQLIK would be the first at-home injection for Alzheimer's treatment. 3. Approval could streamline Alzheimer’s treatment, reducing healthcare resource needs. 4. LEQEMBI already approved in 48 countries, enhancing market access. 5. Product safety includes ARIA risks, especially for ApoE ε4 carriers.