Supplemental Biologics License Application Filed for Leqembi Maintenance Dosing

Eisai recently submitted a supplemental Biologics License Application to the US Food and Drug Administration (FDA) for monthly intravenous (IV) maintenance dosing for lecanemab-irmb (Leqembi), Eisai and partner Biogen Inc. announced. Leqembi is indicated for the treatment of Alzheimer disease (AD) in patients with mild cognitive impairment or mild dementia.

After completion of the biweekly IV initiation phase, the exact period of which is under discussion with the FDA, patients would receive a monthly IV dose as part of the maintenance regimen. The dose would maintain a drug concentration to sustain the clearance of highly toxic protofibrils, which can cause neuronal injury even after the amyloid-beta plaque has been cleared from the brain, the companies explained. The supplemental Biologics License Application is based on modeling of data from a phase 2 study, the Clarity AD study, and their open-label extensions.

Eisai had planned to initiate a rolling Biologics License Application for weekly subcutaneous administration of lecanemab maintenance in March 2024 under the existing Fast Track and Breakthrough Therapy designations. However, the FDA informed Eisai that a Fast Track designation specific to the subcutaneous formulation is required first. Eisai subsequently submitted a request for a Fast Track designation, which should be determined within 60 days of submission.

Leqembi is approved in the United States, Japan, and China for the treatment of AD. The drug is under review in a more than a dozen other countries.

Eisai is leading lecanemab’s development and regulatory submissions globally. Both Eisai and Biogen are commercializing the product.

Reference

Eisai completes submission of Leqembi (lecanemab-irmb) supplemental Biologics License Application for IV maintenance dosing for the treatment of early Alzheimer’s disease to the US FDA. News release. Eisai Co.; April 1, 2024. Accessed April 11, 2024. https://www.eisai.com/news/2024/news202423.html