Growing backlash against the FDA approval of unproven Alzheimer ’s treatment Aduhelm, by Biogen

ICER Issues Statement on the FDA’s Approval of Aducanumab for Alzheimer’s Disease (Institute for Clinical and Economic Review): The Institute for Clinical and Economic Review (ICER) believes that the FDA, in approving aducanumab (Aduhelm™, Biogen) for the treatment of Alzheimer’s disease, has failed in its responsibility to protect patients and families from unproven treatments with known harms. Our review of the evidence was concordant with that of many independent experts: current evidence is insufficient to demonstrate that aducanumab benefits patients. The avenue forward has seemed clear: another study would be needed to reduce the substantial uncertainty about the drug’s effectiveness, a requirement of even greater priority because of the drug’s common and potentially serious side effects. However, instead of waiting for such a trial, the FDA chose to move the goalposts and approve aducanumab based on the surrogate outcome of removing amyloid from the brain rather than the patient-centered outcome of clinical benefit, which has been required of all previous emerging treatments for Alzheimer’s disease. Many other drugs have been shown to remove amyloid from the brain, yet have failed to help patients, making this decision all the more puzzling. Keep reading the important statement HERE, over at ICER website. The Announcement: FDA Grants Accelerated Approval for Alzheimer’s Drug (press release): Today, the U.S. Food and Drug Administration approved Aduhelm ...
Source: SharpBrains - Category: Neuroscience Authors: Tags: Brain/ Mental Health aducanumab Aduhelm Alzheimer’s Disease Alzheimer’s disease treatment amyloid amyloid plaques amyloid-related imaging abnormalities ARIA Biogen brain swelling clinical benefit FDA ICER Janet Woodcock N Source Type: blogs