Federal drug regulators will decide by July 6 whether to grant the first traditional approval to an amyloid-busting drug to treat Alzheimer’s disease.
On June 9, the Food and Drug Administration’s advisory panel of experts endorsed the drug, lecanemab, as effective – while not voting on the thornier question of how to advise doctors and patients about known side effects and medical risks. The FDA doesn’t have to accept its advisory panel’s recommendation when evaluating a drug but often does.
Source link: https://www.usatoday.com/story/news/health/2023/06/20/lecanemab-lequembi-alzheimers-drug-fda-approval-process-side-effects-dementia/70317466007/