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FDA Approves Monthly Dosing for Eisai-Biogen Alzheimer's Drug, Reducing Treatment Frequency
Jan 27, 2025, 11:10 AM
The U.S. Food and Drug Administration (FDA) has approved a monthly maintenance dosing regimen for Leqembi (lecanemab-irmb), an Alzheimer's drug developed jointly by Eisai Co. Ltd. and Biogen Inc., on January 27, 2025. This approval allows patients with early-stage Alzheimer's disease to switch to monthly intravenous infusions, reducing treatment frequency, after completing an 18-month regimen of biweekly dosing. The drug targets amyloid beta, a protein associated with Alzheimer's, and is designed to slow cognitive decline. The companies aim to reduce the treatment burden for patients by potentially introducing home-administered injectable versions in the future. Leqembi is part of a growing class of Alzheimer’s treatments, including Eli Lilly’s rival drug Kisunla, which also offers monthly dosing. Both drugs require monitoring for potential side effects such as brain swelling and bleeding.
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