FDA approves much-debated Alzheimer's drug panned by experts
June 8, 2021
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 approved the drug from Biogen based on study results showing it 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.