Biogen's Alzheimer's drug gets FDA approval
In a landmark decision, the US Food and Drug Administration has approved the first new treatment for Alzheimer’s disease in nearly two decades. There is some debate in the scientific community, however, over whether there is enough evidence that the treatment has significant benefits for patients.
In order to continue marketing the drug, Biogen will need to complete a large clinical trial to confirm that the drug has cognitive benefits, the FDA said.
In approving the drug on a conditional basis, the agency departed from decades of regulatory precedent, setting a new bar for treatments with considerable potential but unproven benefits — a standard that could also be applied to other diseases.
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