Researchers question ‘misleading’ surrogate evidence for FDA’s Aduhelm approval

Last year, 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 amount of the protein “amyloid” in the brain as assessed by amyloid-PET scans and without evidence of significant clinical effect.