U.S. FDA Approves Lecanemab

On July 6, 2023, the U.S. Food and Drug Administration (FDA) approved Leqembi (lecanemab), the second of a new category of medications approved for Alzheimer’s disease. Lecanemab is the first beta amyloid-targeting medication to pass the FDA’s full review.  Additionally, the Centers for Medicare & Medicaid Services (CMS) has announced plans to enable Medicare access to FDA traditionally approved Alzheimer’s treatments. Medicare coverage is expected to expand access to this new class of treatments to adults over 65 who have been unable to afford the $26,500-a-year medication. The manufacturer of Leqembi demonstrated that patients who received a biweekly infusion of the drug declined 27% more slowly than a comparison group who received placebo treatment.

While these medications represent an important advancement in the ongoing fight to effectively treat Alzheimer’s disease, it is important to note that existing FDA-approved medications can have serious side effects including amyloid-related imaging abnormalities (ARIA), which involves brain swelling and/or bleeding. ARIA does not usually cause symptoms but in rare cases can be serious or even fatal if not detected in time. With FDA-approved treatments available for people with early-stage Alzheimer’s, patients and their families are encouraged to have discussions with their health care providers about the potential risks and benefits of existing treatments.

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