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FDA Approves Much-debated Alzheimer's Drug, with Follow-up Study

FDA Approves Much-debated Alzheimer's Drug, with Follow-up Study

Voice of America
Monday, June 07, 2021 10:07:50 PM UTC

WASHINGTON - Government health officials on Monday approved the first new drug for Alzheimer's disease in nearly 20 years, disregarding warnings from independent advisers that the much-debated treatment hasn't been shown to help slow the brain-destroying disease.

The Food and Drug Administration said it approved the drug from Biogen based on results that seemed "reasonably likely" to benefit Alzheimer's patients.   It's the only therapy that U.S. regulators have said can likely treat the underlying disease, rather than manage symptoms like anxiety and insomnia. The decision, which could impact millions of Americans and their families, is certain to spark disagreements among physicians, medical researchers and patient groups. It also has far-reaching implications for the standards used to evaluate experimental therapies, including those that show only incremental benefits.
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