Last 12 months, the FDA gave 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 presumed reduction in the quantity of the protein “amyloid” within the brain as assessed by amyloid-PET scans and without evidence of serious clinical effect.

In a Commentary published within the Journal of Alzheimer’s Disease, authors Poul F. Høilund-Carlsen, Mona-Elisabeth Revheim, Abass Alavi , Nagichettiar Satyamurthy, and Jorge R. Barrio have detailed their views questioning the amyloid hypothesis that has dominated Alzheimer research and treatment trials for 30 years. Particularly they query the usage of amyloid-PET scanning, an imaging procedure that has been used to indicate whether recent therapies are able to scale back cerebral amyloid deposits as that is assumed to inhibit the event of Alzheimer’s disease. They contend that this very finding contributed to the FDA’s approval of Aduhelm contrary to its own independent expert panel which looked in vain for evidence of a good clinical effect.

We imagine this sort of PET scanning is questionable and has misled the FDA into making a call contrary to the agency’s foremost mission to “protect and promote the general public health. Background for the approval is a never proven ‘amyloid hypothesis’ suggesting that Alzheimer’s disease is brought on by cerebral amyloid deposits. As a substitute of reducing the quantity of amyloid within the brain, we fear that Aduhelm and similar drugs cause increased brain damage.”

Abass Alavi, MD, Writer, Department of Radiology, Hospital of the University of Pennsylvania, Philadelphia, PA, USA

Dr. Alavi continued, “Along with our concerns, we suspect that the amyloid PET scans performed should not reflecting amyloid removal, but reasonably are indicative of increased therapy-induced brain damage. We, subsequently, strongly recommend that the FDA puts its Aduhelm approval on hold and requires thorough investigation of our presumption before taking a position on any further Alzheimer immunotherapy applications.”

Source:

Journal reference:

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