U.S. FDA faces mounting criticism over Alzheimer’s drug approval

755449

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….

Want to know more click here go to source.

From -
Close
Generic selectors
Exact matches only
Search in title
Search in content

By continuing to use the site, you agree to the use of cookies. more information

The cookie settings on this website are set to "allow cookies" to give you the best browsing experience possible. If you continue to use this website without changing your cookie settings or you click "Accept" below then you are consenting to this.

Close