FDA Approves LEQEMBI® (Lecanemab-Irmb) IV Maintenance Dosing for Early Alzheimer’s Disease Treatment
Eisai Co., Ltd. and Biogen Inc. announced that the FDA has approved the Supplemental Biologics License Application (sBLA) for LEQEMBI (lecanemab-irmb), allowing intravenous (IV) maintenance dosing every four weeks for patients with early-stage Alzheimer’s disease. LEQEMBI is intended for those in the mild cognitive impairment or mild dementia stages of AD. This new dosing regimen follows an initial 18-month biweekly treatment phase and is designed to maintain the clinical and biomarker benefits observed in pivotal trials like Clarity AD and Study 201.
The decisio...
