This week’s FDA approval of Aduhelm, a new monthly IV infusion to treat amyloid plaques in patients with Alzheimer’s disease, has generated lots of controversy in the medical community. The FDA Advisory Committee voted not to approve this product, and three of its members resigned in protest over the FDA approval. Governmental, professional, and advocacy entities need to tell patients, caregivers, and clinicians about Aduhelm risks and limitations in effectiveness based on the outcome if its two clinical trials. This product is promising, but not the magic bullet because reduction in amyloid plaques alone may not translate into less clinical progression of Alzheimer’s disease. Tell us how you feel about the FDA approval.
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