The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Eisai’s lecanemab, an investigational anti-amyloid beta (Aβ) protofibril antibody, for the treatment of early Alzheimer’s disease (AD). Alzheimer’s disease is a serious and progressive disease that leads to death of nerve cells and tissue loss throughout the brain, ultimately causing the brain to shrink over time and affecting most functionality of the brain. Lecanemab is a monoclonal antibody that works by attaching itself to anti-amyloid beta (Aβ), a peptide around which plaque forms and becomes a strong marker for the disease, further signaling a response from the immune system. Since Alzheimer’s disease is progressive, current treatment options aim to manage behavioral symptoms, maintain mental function, and slow to progression of disease in the brain. The FDA Fast Track designation is designed to expedite the development of new drugs and treatments to meets the needs of serious or life-threatening conditions. The Japanese pharmaceutical company, Eisai, contributes to the research and development of potentially life-saving treatments to better the health of patients and their families.

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