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FDA’s ‘Conundrum’: What To Do With Approved Drugs That Fail Pivotal or Confirmatory Trials (www.biospace.com)

submitted 1 week ago by Icytrees@sh.itjust.works to c/wildfeed@sh.itjust.works

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Joe Ross, professor of medicine and public health at Yale School of Medicine and co-author of the study, told BioSpace he was “surprised to find that about 10% of all approvals are made despite the primary efficacy endpoint being null.” But, he added, “perhaps it isn’t surprising because the FDA has such flexibility in reviewing a marketing application.”

The most notable case—highlighted by the authors—is Biogen’s Aduhelm (aducanumab), greenlit under the FDA’s accelerated approval pathway in June 2021 as the first Alzheimer’s drug to treat the underlying cause of the disease. It was also among the most controversial approvals of the past decade, leading to the resignation of three prominent FDA reviewers.

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[–] MotoAsh@piefed.social 2 points 1 week ago (1 children)

Obviously, you blackmail the pharma corp for millions to keep the drug on the market. ...

[–] Icytrees@sh.itjust.works 1 points 1 week ago

This is about bureaucracy and how structured trials can fail to reveal a drugs efficacy.