FDA head calls for investigation into Alzheimer's drug approval
…The meeting came after Biogen stopped two studies because the drug seemed didn’t seem to slow the disease as intended. Biogen and the FDA began reanalyzing the data together, concluding the drug may actually work. The collaboration ultimately led to the drug’s conditional approval two years later, on the basis that the drug reduced a buildup of sticky plaque in the brain that is thought to play a role in Alzheimer’s disease.
…The FDA has faced an intense public backlash since approving the drug, which costs$56,000-a-yearand requires monthly IVs. On Thursday, the agency took the unusual step of vastly scaling back prescribing information on the drug. The agency and Biogen announced the new label would recommend it only be given to patients with mild or early-stage Alzheimer’s. That came after many doctors criticized the original label as too broad — stating only that it could be used in anyone with Alzheimer’s.
https://www.nbcnews.com/health/health-news/fda-head-calls-investigation-alzheimer-s-drug-approval-n1273555