Opinion: FDA’s updated standards remove an unnecessary barrier to testing Alzheimer’s drugs
The FDA is finally modernizing its approach to evaluating new Alzheimer's drugs.
After years of relying on outdated standards for evaluating new drugs for Alzheimer’s and other neurologic diseases, the FDA is finally modernizing its approach. This is good news for researchers working to develop much-needed medications for these conditions.
The change has to do with the endpoints the FDA requires in clinical trials. A loose standard in place since the 1990s required clinical trials to show that a new drug function. But that isn’t in line with our current understanding of the disease and was likely a contributing factor in the high rate of failure in Alzheimer’s trials.
