09Jul 2023
FDA Approves First Treatment For Alzheimer's Disease

FDA Approves First Treatment For Alzheimer's Disease

The US Food and Drug Administration (FDA) has granted full approval to Lecanemab (Leqembi) as the first treatment for Alzheimer's disease that targets the disease process. Leqembi is an amyloid beta-directed antibody that reduces amyloid plaques in the brain, a characteristic feature of Alzheimer's. The drug was initially approved under the Accelerated Approval pathway, and its conversion to traditional approval was based on a confirmatory trial demonstrating clinical benefit. Leqembi showed significant improvement in cognitive measures compared to a placebo in Phase 3 clinical trial. However, it is associated with potential side effects such as headache and amyloid-related imaging abnormalities, including brain swelling. Leqembi is recommended for use in patients with mild cognitive impairment or mild dementia, as studied in clinical trials.

  • #neurology

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