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….