Posted by Michael Wonder on 15 Jun 2023
New Alzheimer’s drug is a problem for FDA’s pass-fail approach
15 June 2023 - The FDA is slated to soon give full approval to Leqembi, a new medicine for Alzheimer’s disease that offers only modest benefit, could pose worrisome risks and stands to cost the nation $2 billion to $5 billion per year.
But the agency has an all-or-nothing problem. Even when evaluating a drug that’s minimally effective or could carry considerable risks, the FDA’s decision nearly always comes down to accept or reject.
