The U.S. Food and Drug Administration on Friday, Jan. 6, 2023, approved lecanemab, a drug that targets the basic pathophysiology of Alzheimer’s disease. The FDA action is an “accelerated approval” of the drug, and the FDA requests continued diligent gathering of evidence on effectiveness and safety. A decision about full approval is a few weeks or months away and may be positive or negative. Regardless, the accelerated approval is a hopeful step forward.
Alzheimer’s therapies of the future will fall into two categories, those drugs that address the symptoms of Alzheimer’s such as forgetfulness without slowing the pathological changes in the brain, and drugs that will slow the progression of Alzheimer’s pathology in the brain. The second group are called disease-modifying therapies or DMTs. Lecanemab is the first DMT to demonstrate the slowing of Alzheimer’s disease convincingly in international prospective double-blind clinical trials. However, our enthusiasm is tempered by the fact that lecanemab is a drug with modest clinical effects but potentially serious adverse effects.
Presently lecanemab is only available through clinical trials. The possibility of lecanemab becoming available for regular clinical care will depend on the decision of the Centers for Medicare and Medicaid Services and insurance companies on whether to cover or to not cover the cost of the medication. That decision will be made later in the year. Meanwhile, the South Texas Alzheimer’s Disease Research Center (ADRC), a National Institute on Aging Center of Excellence in partnership with UT Rio Grande Valley, is a site of AHEAD, a human clinical research study of lecanemab. To maximize safety, the patient selection criteria are extremely rigorous. Only a few patients with early disease, minimal to no symptoms, and a low bleeding risk are eligible to receive the medication. Past studies of lecanemab have shown there is a risk of brain swelling and hemorrhage in more than 10% of patients. This must be closely monitored. The benefit of the drug therapy appears real but small (half a point on an 18-point scale of function) or equivalent to a few months slowing of disease progression.
We at the Glenn Biggs Institute and South Texas ADRC are closely monitoring all developments and will work with eligible patients to discuss if this option is suitable for them.
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