FDA Grants Accelerated Approval for Anti-Amyloid Therapy, Lecanemab

On January 6, 2023, the FDA granted accelerated approval to Lecanemab (Leqembi). The drug shows a biological effect in removing a hallmark of Alzheimer’s disease pathology, beta-amyloid in individuals with mild symptoms of Alzheimer’s disease.

“While a biological effect is encouraging, what we really want to see is a clinical effect,” says Judy Heidebrink, M.D., M.S., U-M Professor of Neurology and Clinical Core Co-Lead of the Michigan Alzheimer’s Disease Center.

Importantly, Lecanemab appears to slow the cognitive decline of mild Alzheimer’s disease. 

The drug is offered intravenously every two weeks beginning at early stages of the disease.

These results support the accelerated approval of Leqembi, which is based on the observed reduction of amyloid beta plaque, a marker of Alzheimer’s disease. Amyloid beta plaque was quantified using positron emission tomography (PET) imaging to estimate the brain levels of amyloid beta plaque in a composite of brain regions expected to be widely affected by Alzheimer’s disease pathology compared to a brain region expected to be spared of such pathology. 

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Learn more about Lecanemab and other current Alzheimer’s disease clinical trials in this video.