Aducanumab, a controversial Alzheimer’s disease medication with “questionable efficacy,” is under review by the Therapeutic Goods Administration.
In a new paper from the Florey Institute, researchers say “science, not desperation” should guide the process.
Aducanumab is a human monoclonal antibody that selectively reacts with amyloid-β, reducing amyloid plaque.
The most dominant theory about the development of Alzheimer’s disease (AD) is that the initial causative event is a deposition of amyloid-β.
The U.S. Food and Drug Administration (FDA) approved aducanumab for use in AD despite Phase 3 trials being terminated early in 2019 after a futility analysis.
The team says a subsequent post hoc reanalysis of additional data led to [the FDA] approval on 7 June 2021 via the Accelerated Approval Program, not on the basis of demonstrated clinical efficacy, but on the unproven presumption that reduction of amyloid plaques is ‘likely to predict clinical benefit’.
This approval took place despite the recommendations of 10 of the 11 members of the advisory committee (one abstained).
Three FDA advisors subsequently resigned in protest and the FDA commissioner requested an independent inquiry into the process that led to the approval of the drug,” Gleason and colleagues wrote.
So far the evidence does not provide a compelling case for clinical benefit, including two phase 3 trials which found “a small effect size … at 78 weeks … at high but not low dose” in one case, and “no statistically significant benefits” in the other.
The authors also questioned the amyloid-β hypothesis itself, saying “there are no data from clinical trials of aducanumab, or any other source, to indicate that lowering amyloid-β has clear clinically significant benefit.”
The team also said that data from other trials to date suggest that amyloid lowering does not have an appreciable effect on cognition, and in some studies, patients treated with amyloid-β-lowering therapies were cognitively worse.
They concluded that regulatory approval based on a post hoc analysis was akin to “winning a sharpshooter contest by drawing a bull’s-eye around a bullet hole.”
“Disease-modifying therapies for AD are urgently needed, but science, not desperation, should guide the approval process.”
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The paper is published in the Medical Journal of Australia and was conducted by Dr. Andrew Gleason et al.
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