FDA approves novel Alzheimer’s disease drug

The U.S. Food and Drug Administration has approved a supplemental Biologics License Application for the intravenous maintenance dosing of lecanemab-irmb for the treatment of patients with early Alzheimer’s disease.

Researchers found that three years of lecanemab treatment was effective at reducing cognitive decline. The FDA’s approval allows for an intravenous maintenance dosing regimen of the drug once weekly every four weeks among patients who have completed the 18-month biweekly initiation phase of 10 milligrams per kilogram dosing. Discontinuation of the drug led to re-accumulation of brain amyloid as well as reversals of plasma and cerebrospinal fluid biomarker improvements.

The findings demonstrated that prolonged administration of lecanemab may provide clinically meaningful benefits in this patient population.

Read more: Pharmacy Times

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