U.S. 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 U.S. Food and Drug Administration (FDA) said it approved the drug from Biogen based on results that seemed "reasonably likely" to benefit Alzheimer's patients. If the study fails to show effectiveness, the FDA could pull the drug from the market, though it rarely does so. Groups representing Alzheimer's patients and their families say any new therapy — even one of small benefit — warrants approval. With FDA approval, aducanumab is certain to be covered by virtually all insurers.
Source: CBC News June 07, 2021 21:11 UTC