The Alzheimer’s medication Leqembi received fast-tracked approval even though it causes life-threatening adverse events and is targeting a component of the disease that many believe is misunderstood.
STORY AT-A-GLANCE
- The U.S. Food and Drug Administration (FDA) granted accelerated approval for the Alzheimer’s disease drug lecanemab (Leqembi)
- The drug, a monoclonal antibody, binds to amyloid beta in the brain
- The most common reactions included amyloid-related imaging abnormalities, or ARIA, which involves swelling and bleeding in the brain that can be life-threatening. During the trial, ARIA occurred more often in people with the APOE4 gene, which is considered to be the strongest risk factor for Alzheimer’s disease
- Amyloid beta may be a symptom of Alzheimer’s — not the cause — and could even have a protective role in the disease process
- This means drugs that work by reducing amyloid beta may be missing the problem entirely, putting patients at risk of serious adverse events for little to no benefit
The U.S. Food and Drug Administration granted accelerated approval for the Alzheimer’s disease drug lecanemab (Leqembi). The drug, a monoclonal antibody, binds to amyloid beta in the brain.
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