Could changing up regulatory requirements for Alzheimer’s drugs help give desperate patients new options for treatment?
A group of researchers and patient advocates think so. They authored a paper that argues that the Food and Drug Administration should evaluate Alzheimer’s drugs for efficacy in either cognition or function — but not both.
Efficacy and cognition are the main endpoints measured in Alzheimer’s disease. The hallmark of cognitive impairment is memory loss, while functional impairment involves losing the ability to perform tasks of daily living — from reading to going to the bathroom to getting dressed in the morning. Currently, FDA expects drugs to improve both cognition and function.
Obviously Klunk never worked in pharma. 30 years of experience has taught me that getting marginally efficacious drugs approved, then charging obscenely high prices before it is concluded that your drug is a dud is a good business model, because everybody who made their six figure bonuses along the way will be long gone by the time the poo hits the fan.
You should point out that this is really a lobbying group: Registered on 03/26/2017 by Connect 4 Strategies, LLC: http://bit.ly/2pBDMdf
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