Eisai Initiates Rolling BLA To FDA For LEQEMBI For Early Alzheimer's Disease Treatment

(RTTNews) - Eisai Co., Ltd. and Biogen Inc. (BIIB) said that Eisai has initiated the rolling submission of a Biologics License Application or BLA to the U.S. Food and Drug Administration or FDA for lecanemab-irmb (U.S. brand name: LEQEMBI) subcutaneous autoinjector for weekly maintenance dosing after it was granted Fast Track designation by the FDA.

LEQEMBI is indicated for the treatment of Alzheimer's disease (AD) in patients with Mild Cognitive Impairment (MCI) or mild dementia stage of disease.

If approved by the FDA, the LEQEMBI autoinjector could be used to administer LEQEMBI at home or at medical facilities. The injection process requires less time than the IV formulation, the companies said.

As part of the subcutaneous autoinjector 360 mg weekly maintenance regimen under review, patients who have completed the biweekly IV initiation phase would receive weekly doses that maintain effective drug concentrations to sustain the clearance of highly toxic protofibrils which can continue to cause neuronal injury even after the amyloid-beta plaque has been cleared from the brain.

The companies noted that LEQEMBI is now approved in the U.S., Japan and China, and applications have been submitted for review in the European Union, Australia, Brazil, Canada, Hong Kong, Great Britain, India, Israel, Russia, Saudi Arabia, South Korea, Taiwan, Singapore and Switzerland.

Eisai submitted to the FDA a Supplemental Biologics License Application (sBLA) for monthly LEQEMBI intravenous (IV) maintenance dosing in March 2024.

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