June 5, 2021

Alzheimer’s Drug Poses a Dilemma for the F.D.A.

By Pam Belluck Rebecca Robbins

1,853 words

If the agency approves it, aducanumab would be the first new Alzheimer’s treatment since 2003. Patients are desperate for new options, but some scientists say there isn’t enough evidence it works.

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Refreshed on June 20, 2021 at 8:50:03 am

Headlines and popularity

  1. The decision was one of the F.D.A.’s most contentious in years.
  2. Alzheimer’s Drug Poses a Dilemma for the F.D.A.
  3. Could This Drug Help Treat Alzheimer’s? It Poses a Dilemma for the F.D.A.
  4. This Drug Could Help Treat Alzheimer’s. It Poses a Dilemma for the F.D.A.

Revisions

June 20, 2021 at 8:50 am CHANGED
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  Excitement about aducanumab grew after a small early trial to evaluate safety showed amyloid reduction and hinted it might slow cognitive decline. The F.D.A., in a move some experts question, allowed Biogen to skip Phase 2 trials and conduct two Phase 3 trials of about 1,640 patients each.
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  Both trials were stopped early, in March 2019, when an independent data monitoring committee said aducanumab didn’t appear to be working. Consequently, 37 percent of participants never completed the 78-week trials.
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- But that October, Biogen announced it found benefit in one trial after evaluating data from 318 participants who finished before the trials were stopped but after the cutoff point for results the monitoring committee assessed.
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+ But that October, Biogen announced it found benefit in one trial after evaluating data from 318 participants who finished before the trials were stopped but after the cutoff point for results the monitoring committee assessed.
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  In that trial, Biogen said, the highest dose slowed cognitive decline by 22 percent, or about four months over 18 months. A lower dose in that trial and high and low doses in the other showed no statistically significant benefit over a placebo.
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  “One study was positive, and one identically performed study was negative,” said Dr. David Knopman, a clinical neurologist at the Mayo Clinic and a site principal investigator for one trial. “I don’t think it takes a Ph.D. in statistics to see that that’s inconclusive.”

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Headlines

  • Alzheimer’s Drug Poses a Dilemma for the F.D.A.
  • The decision was one of the F.D.A.’s most contentious in years.
  • Could This Drug Help Treat Alzheimer’s? It Poses a Dilemma for the F.D.A.
  • This Drug Could Help Treat Alzheimer’s. It Poses a Dilemma for the F.D.A.

Tags

  • Aducanumab (drug)
  • Alzheimer's Assn
  • Alzheimer's Disease
  • Biogen Inc
  • Brain
  • Clinical Trials
  • Drugs (Pharmaceuticals)
  • Elderly
  • Food and Drug Administration
  • Memory
  • your-feed-healthcare
  • your-feed-science