How did Anuhelm, a new drug for Alzheimer’s disease, get approved? Elizabeth Tracey reports
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Aducanumab or Aduhelm is a newly approved medicine for treating Alzheimer’s disease, with many experts asserting that it should never have gotten FDA approval. Caleb Alexander, an internal medicine expert at Johns Hopkins and a member of the FDA review panel that recommended against approval, says the agency chose what is known as a ‘surrogate’ endpoint, kind of a midpoint, rather than clinical benefit.
Alexander: Towards the end of the review process the FDA decided rather than approving it based on its demonstrated clinical evidence they approved it based on the product’s ability to lower amyloid in the brain. But there’s a lot of uncertainty as to whether or not amyloid is a valid surrogate. There have been many studies that have been performed that show products that can successfully reduce amyloid, with no improvement in the symptoms that we all care about- language, memory, cognition. :31
At Johns Hopkins, I’m Elizabeth Tracey.