AI Article Synopsis
- The FDA's approval of aducanumab (Aduhelm®) for mild cognitive impairment and Alzheimer's disease has sparked serious concerns over its effectiveness and safety.
- Biogen's marketing license for aducanumab is called into question due to its failure to show real benefits and non-compliance with regulatory standards.
- There are fears that this drug could cause harm at both personal and societal levels, suggesting a need for its immediate withdrawal from the market.
Article Abstract
U.S. Food and Drug Administration-s (FDA) approval of aducanumab (Aduhelm® in the US) as a treatment for mild cognitive impairment of the Alzheimer type and Alzheimer-s disease has raised such major concerns about efficacy, safety, FDA processes, and regulatory capture that Biogen-s license to market this biologic should be immediately withdrawn. Aducanumab has not demonstrated benefit to patients, failed to meet regulatory guidelines, and is likely to cause both individual and societal harm.
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| http://dx.doi.org/10.3233/JAD-220264 | DOI Listing |
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