Final 12 months, the FDA gave accelerated approval of the antibody aducanumab (marketed as Aduhelm by Biogen) for the therapy 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 medical impact.
In a Commentary revealed 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 therapy trials for 30 years. Particularly they query using amyloid-PET scanning, an imaging process that has been used to point out whether or not new therapies are in a position to cut 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 skilled panel which seemed in useless for proof of a positive medical impact.
We imagine this type of PET scanning is questionable and has misled the FDA into making a choice 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 brought on by cerebral amyloid deposits. As an alternative of lowering the quantity of amyloid within the mind, we worry that Aduhelm and comparable medication trigger elevated mind harm.”
Abass Alavi, MD, Writer, Division of Radiology, Hospital of the College of Pennsylvania, Philadelphia, PA, USA
Dr. Alavi continued, “Along with our issues, we suspect that the amyloid PET scans carried out usually are not reflecting amyloid removing, however fairly are indicative of elevated therapy-induced mind harm. We, due to this fact, 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 functions.”
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.