New Alzheimer’s Disease Drugs — Science Should Lead Approval, Not Despair: Experts

Aducanumab, a drug for Alzheimer’s disease, is being considered by the Therapeutic Products Administration, but the author of the outlook is Medical Journal of Australia “Science, not despair” should guide the process.

Aducanumab is a human monoclonal antibody that selectively reacts with amyloid β to reduce amyloid plaque. The most predominant theory for the development of Alzheimer’s disease (AD) is that the first causative event is the deposition of amyloid-β.

The US Food and Drug Administration (FDA) has approved the use of aducanumab in AD, but a futile analysis has shown that Phase 3 trials were completed in early 2019.

“By subsequent post-reanalysis of additional data, [the FDA] June 7, 2021 by a accelerated approval program based on unproven estimates that reduction of amyloid plaques “is likely to predict clinical benefit” rather than based on proven clinical efficacy “Approval,” wrote the MJA author, led by Dr. Andrew Gleason. , From the Melbourne Dementia Research Center at Flory Institute.

“This approval was given despite the recommendation of 10 of the 11 members of the Advisory Board (one abstaining), after which three FDA advisors resigned in protest and the FDA Commissioner. Requested an independent investigation into the process leading to drug approval, “Gleason and colleagues write.

“Proponents of approval, including the FDA and the Alzheimer’s Association, argue that AD is a serious illness with unmet needs and that patients need to be allowed if the drug has the potential to benefit. And defended the decision. Access while more data is being collected. “

So far, the evidence has not provided “a compelling case for clinical benefit,” Gleason and colleagues wrote. On the other hand, “there is no statistically significant advantage.”

The authors also questioned the amyloid β hypothesis itself: “There are no data from clinical trials of aducanumab or other sources showing that lowering amyloid β clearly provides clinically significant benefits.” Stated.

“Data from other studies to date suggest that amyloid lowering does not have a perceptible effect on cognition, and some studies have shown that patients treated with amyloid β-lowering therapy are cognitively lower. It got worse. “

Gleason et al. Conclude that regulatory approval based on post-mortem analysis is similar to “winning a sniper contest by catching an eye around the hole in the ammunition.”

“Premature approval without evidence of clinically meaningful benefits from controlled clinical trials is costly for the government and patients (exposed to side effects) and is adopted for placebo controlled clinical trials. From the development of more effective treatments that can be difficult and can divert research funding, “they wrote.

“There is an urgent need for disease-modifying therapies for AD, but science should guide the approval process, not despair.”

Image credit: © stock.adobe.com / au / Bulat

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