Third member of prestigious FDA panel resigns over approval of Biogen’s Alzheimer’s drug

936395

Sumary of Third member of prestigious FDA panel resigns over approval of Biogen’s Alzheimer’s drug:

  • Dr. Aaron Kesselheim, a professor of medicine at Harvard Medical School, said the agency’s decision on Biogen “was probably the worst drug approval decision in recent U.S..
  • “At the last minute, the agency switched its review to the Accelerated Approval pathway based on the debatable premise that the drug’s effect on brain amyloid was likely to help patients with Alzheimer’s disease,”.
  • to him that the agency is not “presently capable of adequately integrating the Committee’s scientific recommendations into its approval decisions.”.
  • The FDA approved the drug under a program called accelerated approval, which is usually used for cancer medications, expecting the drug would slow the cognitive decline in Alzheimer’s patients….

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