• Patient Perspectives on the Regulatory Review of Tavneos (avacopan)

  • The National Kidney Foundation (NKF) and Vasculitis Foundation (VF) are working together to learn more about patients’ thoughts and experiences related to the FDA review of Tavneos (avacopan), a medicine approved in 2021 to treat ANCA-associated vasculitis (in combination with steroids).

    The U.S. Food & Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) has suggested removing Tavneos (avacopan) from the market. According to the FDA, this suggestion is based on:

    1) New information that raises questions about whether Tavneos (avacopan) works as well as expected for its approved use, and

    2) Concerns the FDA has about whether some information in the original approval application was accurate.

    Tavneos (avacopan) is still available while the FDA review continues. Treatment decisions about whether to start or continue Tavneos (avacopan) are highly individualized and should involve a shared-decision-making approach. Do not stop or change your treatment without first discussing it with your healthcare team.

    This survey will ask about your awareness, opinions, and experiences related to this FDA proposal.

    This survey takes about 15 minutes to complete.

    You may stop and come back to it at any time.

  • Section 1: Awareness & Understanding

  • 1. Before starting this survey, were you aware of the FDA proposal to remove Tavneos (avacopan) from the market?*
  • 2. How familiar are you with the proposal to remove Tavneos (avacopan) from the market?*
  • 3. How did you first learn about the proposal regarding Tavneos (avacopan)? (Select all that apply.)*
  • 4. What is your experience with Tavneos (avacopan)?*
  • 5. How long have you been taking Tavneos (avacopan)?*
  • 6. How long were you taking Tavneos (avacopan) before stopping it?*
  • 7. Who made the decision to stop taking Tavneos (avacopan)?*
  • 8. What type of healthcare provider was involved in the decision to stop Tavneos (avacopan)?*
  • 9. What treatments are you taking (or have taken) for ANCA-associated vasculitis? (Select all that apply)*

  • Section 2: Potential Impact on Treatment

  • 10. How has this news affected your ANCA-associated vasculitis treatment plan?*
  • 11. Have you talked about this news with your healthcare provider?*
  • 12. Which of the following issues raised by the FDA about Tavneos (avacopan) are most important to you? (Select all that apply.)*
  • 13. How would you describe your current view of the risks and benefits of Tavneos for treating your ANCA-associated vasculitis?*
  • 14. How has this recent news about Tavneos made you feel?*

  • Section 3: Trust & Regulatory Confidence

  • Rows

  • Section 4: Educational & Support Needs

  • 16. What information would help you most right now? (Select all that apply.)*
  • 17. What resources or types of support would be most helpful to you regarding the Tavneos (avacopan) situation? (Select all that apply.)*

  • Section 5: General Demographic Information

  • 19. What is your connection with vasculitis?*
  • 20. Where do you receive your vasculitis care?*
  • 21. What is your age?*
  • 22. What is your sex?*
  • 23. What is your race or ethnicity? (Select all that apply)*
  • 24. How many years have you been living with ANCA-associated vasculitis?*
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