FDA Tweak Could Be Boon for Alzheimer's Drugs

Proposal could make it easier to get early-stage drugs OKed

By Mark Russell,  Newser Staff

Posted Mar 14, 2013 10:22 AM CDT

(Newser) – Good news in the Alzheimer's arena: The FDA could ease the rules for approving new drugs to treat the disease, reports the New York Times. Under the proposed plan, the FDA would be able to OK drugs that returned improved results on memory or reasoning tests in clinical trials involving people in the early stages of the disease. Currently, getting that approval means also showing the drug improves sufferers' daily functioning, like feeding and dressing themselves, and that's created a problem—how can you show a drug works on patients in such an early stage of the disease that their daily functioning hasn't perceptibly deteriorated?

While the Times believes the move could make things much easier for the pharmaceutical industry and researchers, which "often felt stymied" by the FDA's rules, a Genentech VP doesn't see smooth sailing ahead, saying it may be tough to develop tests that can reveal these "subtle" cognitive changes. Others are more enthused. "There is more motivation now to invest in the field," said one scientist. "This is really a huge advance,” said a senior researcher at Eli Lilly. "Kudos to the FDA."

The FDA has proposed changing how it approves drugs for fighting Alzheimer's disease.
The FDA has proposed changing how it approves drugs for fighting Alzheimer's disease.   (Shutterstock)
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