US health officials have approved Aduhelm, the first new drug for Alzheimer’s disease in nearly 20 yearsUS 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 hasn’t been shown to help slow the brain-destroying disease. The Food and Drug Administration said it granted approval to the drug from Biogen based on results that seemed “reasonably likely” to benefit Alzheimer’s patients. The new drug, which Biogen developed with Japan’s Eisai, did not reverse mental decline, only slowing it in one study. Read More“The FDA gets the respect that it does because it has regulatory standards that are based on firm evidence. Under the accelerated approval, the FDA is requiring the drugmaker to conduct a follow-up study to confirm benefits for patients.
Source: Irish Independent June 08, 2021 00:56 UTC