US government health officials approved the first new drug for Alzheimer’s disease in nearly 20 years, disregarding warnings from independent advisers that the much-debated treatment has not been shown to help slow the brain-destroying disease. The Food and Drug Administration said it granted approval to the drug developed by Biogen for patients with Alzheimer’s disease. On one side, groups representing Alzheimer’s patients and their families say any new therapy, even one of small benefit, warrants approval. The approval came despite a scathing assessment in November by the FDA’s outside panel of neurological experts. Cambridge, Massachusetts-Biogen halted two studies of the drug in 2019 after disappointing results suggested aducanumab would not meet its goal of slowing mental and functional decline in Alzheimer’s patients.
Source: Irish Independent June 07, 2021 15:39 UTC