In a move that was met with widespread approval from Big Pharma, the FDA announced that it plans to loosen the regulations for approving new treatments for Alzheimer’s disease.
The shift could be a huge benefit for those at risk of, or currently suffering from early stages of the disease.
Since the beginning of the century, Alzheimer’s drugs could only win approval from the FDA if they enabled patients in performing daily activities like feeding, dressing or bathing themselves.
According to the new FDA proposal, which was recently published in the New England Journal of Medicine, treatments in clinical trial would be eligible for approval if patients in early stages of the disease subtly improved their memory or reasoning abilities when tested. Drug makers would not have to show that the drugs improved the ability to perform tasks on a day-to-day basis.
“Our goal was to provide as much regulatory clarity as possible,” said Dr. Nicholas Kozauer, a clinical team leader in the agency’s division of neurology products. “We would encourage companies to start thinking along these lines.”
Drugs for Early Alzheimer’s Already Being Tested
Before the announcement, several companies had already been looking into treating the disease in its earliest stages. One of those efforts, led by Dr. Paul S. Aisen of the University of California, San Diego, and Dr. Reisa Sperling of Harvard University, will focus on 70-year-olds who show no symptoms of the disease, but do have amyloid plaques in their brains, a tell-tale sign of higher Alzheimer’s risk.
The drug maker Lilly has also scheduled testing for a new drug designed to be given during the earliest stages of Alzheimer’s. Earlier tests of the drug had failed, but an academic review of the data found that the drug did benefit patients in the early stages of Alzheimer’s when it came to performing memory tests.
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