FDA approves lecanemab to slow progression of Alzheimer’s disease, with mixed reactions.
The Food and Drug Administration (FDA) recently approved a drug, called lecanemab, to help patients in the early stages of Alzheimer’s by slowing down the progression of the disease. This is the second drug to receive fast-track approval from the FDA, and the decision has been met with both praise and skepticism.
Over 6 million people in the United States are living with Alzheimer’s, an incurable and fatal disease that affects the brain and causes loss of cognitive function over time. Lecanemab is the first drug to address the underlying cause of the disease, and has been welcomed by some doctors as a groundbreaking treatment. However, others are skeptical of the drug’s efficacy and the FDA’s decision to give it accelerated approval.
Lecanemab is a monoclonal antibody therapy that is designed to remove a substance called beta-amyloid from the brain. Beta-amyloid is a naturally occurring protein that becomes toxic when it clumps together and forms the sticky plaques that are a hallmark of Alzheimer’s disease. In a clinical study of nearly 1,800 people in the early stages of Alzheimer’s, those who were given lecanemab for 18 months experienced 27% less decline in memory and thinking compared with those who received a placebo.
The drug will be marketed as Leqembi and is administered through intravenous infusions every two weeks. It is costly, with an annual price of $26,500, and the Centers for Medicare and Medicaid Services (CMS) has said it will not cover the drug for the general population. Some experts worry that the approval of lecanemab will incentivize drug companies to focus on therapies targeting amyloid plaques while neglecting other treatment approaches that may be more fruitful.
The side effects of lecanemab include brain swelling and bleeding, and there have been at least three deaths linked to the drug. However, experts stress that these side effects should not be a reason for doctors and patients in the early stages of the disease not to consider the medication. Ultimately, individuals should weigh the potential benefits and risks of the drug in conversation with their clinician.