The US FDA approved lecanemab, the second-ever treatment for Alzheimer’s disease that is intended to tackle the root of the condition and the slow cognitive decline that results. Clinicians welcome the decision, but their excitement is clouded by reports of patient deaths and that the FDA acted improperly last year when approving the first drug of this kind.

Lecanemab (named Leqembi) is the first Alzheimer’s treatment of its kind shown to slow cognitive decline in a robust clinical trial and is the second treatment to be approved in under two years. It is made by the bio-pharmaceutical companies Eisai in Tokyo, and Biogen in Cambridge, Massachusetts. The drug, a monoclonal antibody, is infused into a patient intravenously; it then enters their brain and clears the amyloid plaques thought to cause cognitive impairment and dementia in Alzheimer’s disease.

In recent months, Science and STAT News have reported on three patients who had been enrolled in the lecanemab phase III study and then died during the extended phase of the trial, when participants receiving placebos can ask to be given the actual drug. The three people died from complications such as brain bleeding and seizures. According to those reports, researchers think that the patients might have died because of a set of conditions known as amyloid-related imaging abnormalities (ARIA). They suspect that the antibody weakened blood vessels in the brain as it attacked the amyloid plaques lining them. All the patients were taking anticoagulant drugs at the time, which might have worsened the bleeding.

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References

  1. FDA approves Alzheimer’s drug lecanemab amid safety concerns. (2023, January 10). Nature. https://www.nature.com/articles/d41586-023-00030-3?utm_source=Nature+Briefing&utm_campaign=33d9dd6146-briefing-dy-20230109&utm_medium=email&utm_term=0_c9dfd39373-33d9dd6146-47677880

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