F.D.A. Approves Alzheimer's Drug Despite Fierce Debate Over Whether It Works - The New ... - 0 views
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The Food and Drug Administration on Monday approved the first new medication for Alzheimer’s disease in nearly two decades, a contentious decision, made despite opposition from the agency’s independent advisory committee and some Alzheimer’s experts who said there was not enough evidence that the drug can help patients.
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The drug, aducanumab, which go by the brand name Aduhelm, is a monthly intravenous infusion intended to slow cognitive decline in people in the early stages of the disease, with mild memory and thinking problems. It is the first approved treatment to attack the disease process of Alzheimer’s instead of just addressing dementia symptoms.
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During the several years it could take for that trial to be concluded, the drug will be available to patients, the agency said. If the post-market study, called a Phase 4 trial, fails to show the drug is effective, the F.D.A. can — but is not required to — rescind its approval.
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