FDA Panel Unanimously Recommends Approval of Alzheimer’s Drug Leqembi

If approved by the FDA, Leqembi would be the first drug shown to slow cognitive decline in Alzheimer’s patients, though it does not cure the disease.
Leqembi works by binding to amyloid beta plaques in the brain, a hallmark of Alzheimer's disease.
Clinical trials showed Leqembi slowed cognitive decline by 27% compared to placebo over 18 months of treatment.
While Leqembi was associated with some serious side effects like brain swelling in some patients, especially those with two copies of the Alzheimer's risk gene APOE4, FDA staff said the benefits outweighed the risks.
Traditional FDA approval of Leqembi is expected to expand Medicare coverage of the drug and lead to over $1 billion in sales by 2026 according to analysts.