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Amyloid PET scanning led the FDA to grant approval for Aduhelm
Last year, the FDA granted accelerated approval of the antibody aducanumab (marketed as Aduhelm by Biogen) for the treatment of Alzheimer's disease. The approval was based solely on a suspected reduction in the amount of the protein “amyloid” in the brain, as detected by amyloid PET scans, and without evidence of a significant clinical effect. In a commentary published in the Journal of Alzheimer's Disease, authors Poul F. Høilund-Carlsen, Mona-Elisabeth Revheim, Abass Alavi, Nagichettiar Satyamurthy and Jorge R. Barrio detailed their views and questioned the amyloid hypothesis, which has dominated Alzheimer's research and treatment trials for 30 years. In particular, they introduce the use of amyloid PET scanning...
Amyloid PET scanning led the FDA to grant approval for Aduhelm
Last year, the FDA granted accelerated approval of the antibody aducanumab (marketed as Aduhelm by Biogen) for the treatment of Alzheimer's disease. The approval was based solely on a suspected reduction in the amount of the protein “amyloid” in the brain, as detected by amyloid PET scans, and without evidence of a significant clinical effect.
In a commentary published in the Journal of Alzheimer's Disease, authors Poul F. Høilund-Carlsen, Mona-Elisabeth Revheim, Abass Alavi, Nagichettiar Satyamurthy and Jorge R. Barrio detailed their views and questioned the amyloid hypothesis, which has dominated Alzheimer's research and treatment trials for 30 years. In particular, they question the use of amyloid PET scanning, an imaging technique that has been used to show whether new therapies are able to reduce cerebral amyloid deposits, as this is thought to inhibit the development of Alzheimer's disease. They claim that this very finding contributed to the FDA's approval of Aduhelm, in contrast to its own independent panel of experts, which searched in vain for evidence of a beneficial clinical effect.
We believe these types of PET scans are questionable and have led the FDA to make a decision that contradicts the agency's primary mission of "protecting and promoting the public health." caused by cerebral amyloid deposits. Instead of reducing the amount of amyloid in the brain, we fear that Aduhelm and similar drugs are causing increased brain damage.”
Abass Alavi, MD, Author, Department of Radiology, Hospital of the University of Pennsylvania, Philadelphia, PA, USA
Dr. Alavi continued: "In addition to our concerns, we suspect that the amyloid PET scans performed do not reflect amyloid removal, but rather indicate increased therapy-induced brain damage. We therefore strongly recommend that the FDA issue its Aduhelm approval suspended and requires a thorough investigation of our suspicion before commenting on further applications of Alzheimer's immunotherapy."
Source:
Reference:
Høilund-Carlsen, PF., et al. (2022) Amyloid PET: A questionable single primary surrogate efficacy measure in Alzheimer's disease immunotherapy trials. Journal of Alzheimer's Disease. doi.org/10.3233/JAD-220841.
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