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Preparing for the FDA Panel on Aducanumab: What might panel members, the agency, and physicians be thinking about Biogen's application days before the Ad-com?

Ticker(s): BIIB

Who's the expert?

Name: Dr Jeffrey Cummings - MD

Institutional: UNLV | Research Professor, School of Integrated Health Sciences 

  • Previously: (until 2019)  
    • Founding director of the Cleveland Clinic Lou Ruvo Center for Brain Health in Las Vegas. 
    • Director of Alzheimer’s Disease Research, Center for Neurotherapeutics, both at UCLA.
  • Ranked in the top 0.01% of scientists and #5 in Alzheimer's disease research in a recent publication in PLoS Biology.
  • Published nearly 800 articles and 44 books devoted to neuroscience, Alzheimer’s disease, and clinical trials. Lead author on: "Drug development in Alzheimer's disease: the path to 2025" 

Interview Goal
This conversation will look at the big questions the FDA will want panel members to address:
  • Do the efficacy data demonstrate in a convincing and meaningful way that aducanumab slows the progression of Alzheimer’s disease in patients with early or mild symptoms?
  • Is aducanumab sufficiently safe to administer to these Alzheimer’s patients? Specifically, are the reported cases of brain swelling and bleeding attributed to aducanumab a safety risk that can be adequately monitored and managed?
  • Does the overall clinical benefit of aducanumab outweigh its safety risk enough to support the drug’s approval to treat Alzheimer’s patients?

Are You Interested In These Questions?



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