FDA Gives Accelerated Approval for Risky Alzheimer’s Pill

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 l…