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FDA panel reviews 1st new Alzheimer’s drug in 2 decades
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One of the biggest drug decisions in decades is looming as U.S. regulators consider whether to approve the first medicine that’s claimed to slow mental decline from Alzheimer’s disease, the most common form of dementia.
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A panel of outside experts meets Friday to advise the Food and Drug Administration on aducanumab, a drug from Cambridge, Mass.-based Biogen Inc. and Japan’s Eisai Co. The FDA doesn’t always follow the panel’s advice but usually does and has until March to decide.
The drug does not cure or reverse Alzheimer’s; the claim is that it modestly slows the rate of decline.
BIOGEN, AT A CROSSROADS, SURGES ON PROMISING ALZHEIMER’S DRUG ASSESSMENT
The evidence is murky: The companies stopped two studies last year when the drug didn’t seem to work, then did an about-face and said additional results suggest it was effective in one study at a high dose. Results still have not been published.
An FDA staff report released Wednesday gave a generally glowing view, saying the positive study might be “exceptionally persuasive.” But an FDA statistician noted flaws and inconsistencies in the results and potential safety issues.