Sep. 3 at 2:40 AM
$BIIB 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
Eisai and Biogen announced Eisai has begun a rolling sBLA submission to the FDA for LEQEMBI IQLIK, a subcutaneous autoinjector of lecanemab designed for early Alzheimer’s patients. The submission seeks approval for use as a once-weekly starting dose following the FDA’s Fast Track designation. LEQEMBI is already approved for Mild Cognitive Impairment and mild dementia stages of Alzheimer’s.