FDA fully approves Alzheimer’s medication Leqembi (lecanemab-irmb)

Scientific image of beta amyloid plaques

On July 6, the U.S. Food and Drug Administration (FDA) approved Leqembi (lecanemab-irmb), a therapy for Alzheimer’s disease shown to slow the cognitive decline associated with the disease. Leqembi is the first amyloid beta-directed antibody to be converted from an accelerated approval to a traditional approval for the treatment of Alzheimer’s disease. The drug works by reducing amyloid plaques that form in the brain and is used in patients with mild cognitive impairment (MCI) or mild dementia stage of Alzheimer’s disease.

“Today’s action is the first verification that a drug targeting the underlying disease process of Alzheimer’s disease has shown clinical benefit in this devastating disease,” said Teresa Buracchio, acting director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research. “This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer’s disease.”

The FDA published its news release "FDA Converts Novel Alzheimer’s Disease Treatment to Traditional Approval” on July 6, 2023.