Sumary of U.S. FDA approves 1st new Alzheimer’s drug in nearly 20 years:
- American government health officials on Monday approved the first new drug for Alzheimer 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 decision, which could impact millions of older Americans and their families, is certain to spark disagreements among physicians, medical researchers and patient groups..
- Dementia, Alzheimer most common disease associated with COVID-19 deaths, says StatCan The new drug, which Biogen developed with Japan Eisai Co., did not reverse mental decline, only slowing it in one study..
- Under terms of the so-called accelerated approval, the FDA is requiring the drugmaker to conduct a follow-up study to confirm benefits for patients..
- If the study fails to show effectiveness, the FDA could pull the drug from the market, though the agency rarely does so..
- A preliminary analysis by one group found that the drug would need to be priced $2,500 to $8,300 per year to be a good value based on the “small overall health gains”.
- The pharmaceutical industry drug pipeline has been littered for years with failed Alzheimer treatments, representing billions in research costs..
- Researchers don’t fully understand what causes Alzheimer but there broad agreement that the brain plaque targeted by aducanumab is just one factor….