Sumary of U.S. FDA faces mounting criticism over Alzheimer’s drug approval:
- In these cases, the agency requires that drugmakers conduct additional clinical trials to prove their therapy works, or face withdrawal from the market..
- In addition, the FDA approval ignored the recommendation of its outside advisers, who said Biogen did not provide enough evidence of clinical benefit..
- Biogen has said that some 1.5 million Americans with early-stage Alzheimer will be eligible for the drug, priced at an average of $56,000 per year, with the federal Medicare insurance program for seniors likely on the hook for most of the cost..
- The FDA approval allows Biogen to sell its product over several years — with forecasts for potential annual sales reaching as high $10 billion to $50 billion — until the company completes a required follow-up study..
- Biogen research chief Alfred Sandrock said the FDA had painstakingly analyzed its clinical trial data over two years before reaching a conclusion..
- The FDA has defended its decision by saying that Biogen presented clear evidence that Aduhelm, known chemically as aducanumab, removed beta amyloid from the brains of people with Alzheimer ..
- However, none of the earlier drugs have shown that reductions in amyloid resulted in significant benefits for patients by slowing deteriorating cognition or ability to function..
- Dr. Peter Stein, director of the FDA Office of New Drugs, said that Aduhelm showed the clearest correlation so far between a reduction in beta amyloid and a delay in cognitive decline among patients, suggesting it was a good predictor of clinical benefit….