FDA Approves Much-debated Alzheimer's Drug, with Follow-up Study
Voice of America
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.Young women and their coach Dioguinho bring it in for a team huddle at the start of a football training session run by the Bola de Ouro social program, at the Complexo da Alemao favela in Rio de Janeiro, Brazil, May 16, 2024. Agatha strikes a ball during a football training session run by the Bola de Ouro social program, at the Complexo da Alemao favela in Rio de Janeiro, Brazil, May 16, 2024. Relatives watch a football training session for young women run by the Bola de Ouro social program at the Complexo da Alemao favela in Rio de Janeiro, Brazil, May 16, 2024.
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