Amyloid-PET scanning has misled the FDA into granting approval for Aduhelm

Amyloid-PET scanning has misled the FDA into granting approval for Aduhelm

Final yr, the FDA gave accelerated approval of the antibody aducanumab (marketed as Aduhelm by Biogen) for the remedy of Alzheimer’s illness. The approval was primarily based solely on a presumed discount within the quantity of the protein “amyloid” within the mind as assessed by amyloid-PET scans and with out proof of serious scientific impact.

In a Commentary printed within the Journal of Alzheimer’s Illness, authors Poul F. Høilund-Carlsen, Mona-Elisabeth Revheim, Abass Alavi , Nagichettiar Satyamurthy, and Jorge R. Barrio have detailed their views questioning the amyloid speculation that has dominated Alzheimer analysis and remedy trials for 30 years. Particularly they query the usage of amyloid-PET scanning, an imaging process that has been used to indicate whether or not new therapies are capable of scale back cerebral amyloid deposits as that is assumed to inhibit the event of Alzheimer’s illness. They contend that this very discovering contributed to the FDA’s approval of Aduhelm opposite to its personal unbiased knowledgeable panel which appeared in useless for proof of a positive scientific impact.

We consider this sort of PET scanning is questionable and has misled the FDA into making a call opposite to the company’s foremost mission to “shield and promote the general public well being. Background for the approval is a by no means confirmed ‘amyloid speculation’ suggesting that Alzheimer’s illness is attributable to cerebral amyloid deposits. As a substitute of decreasing the quantity of amyloid within the mind, we worry that Aduhelm and related medication trigger elevated mind injury.”

Abass Alavi, MD, Writer, Division of Radiology, Hospital of the College of Pennsylvania, Philadelphia, PA, USA

Dr. Alavi continued, “Along with our considerations, we suspect that the amyloid PET scans carried out usually are not reflecting amyloid elimination, however slightly are indicative of elevated therapy-induced mind injury. We, subsequently, strongly advocate that the FDA places its Aduhelm approval on maintain and requires thorough investigation of our presumption earlier than taking a place on any additional Alzheimer immunotherapy purposes.”

Supply:

Journal reference:

Høilund-Carlsen, P.F.., et al. (2022) Amyloid PET: A Questionable Single Main Surrogate Efficacy Measure on Alzheimer Immunotherapy Trials. Journal of Alzheimer’s Illness. doi.org/10.3233/JAD-220841.

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