FDA approves first drug to slow decline of Alzheimer’s disease

But in a nod to the controversy surrounding the drug, the FDA is directing the manufacturer, the biotech giant Biogen, to conduct a post-approval study confirming that the medication works. The requirement, part of a program called accelerated approval, is designed to allow for earlier approval of drugs that treat serious or life-threatening conditions and meet an unfilled medical need. Such approvals are based on a “surrogate endpoint” — in this case, the medication’s ability to reduce clumps of amyloid plaque in the brain, a hallmark of Alzheimer’s disease.

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