Vasculitis Foundation Canada
AdvocacyOppose
Patient experience with avacopan
Patient quality of life
Patient safety and access
ChemoCentryx, Inc.; Proposal To Withdraw Approval of New Drug Application for TAVNEOS (Avacopan) Capsule, 10 Milligrams; Opportunity for a Hearing
FDA-2026-N-1321-0001Notice
Comments
94
Last activity Jun 29, 2026
Deadline
Closed on Jun 30, 2026
Closed Jun 30, 2026
Net supportiSupport minus oppose · campaigns included
-54%
-54% excluding campaigns
Document
Details
The document's own metadata, straight from the source system.
- Title
- ChemoCentryx, Inc.; Proposal To Withdraw Approval of New Drug Application for TAVNEOS (Avacopan) Capsule, 10 Milligrams; Opportunity for a Hearing
- Posted
- Apr 30, 2026
- Comment period
- Apr 30, 2026 – Jun 30, 2026
- FR Doc
- 2026-08455
- Topics
Analysis
Overview
What the public is saying — stance, who's commenting, and the issues they raise.
Include campaigns
Stance breakdown
-54%
Net support
Support19Oppose70Other5
Aggregates include form-letter campaigns. Excluding them, net support is -54% across organic comments.
Who commented
Breakdown by commenter type.
Business
2
Individual
88
Advocacy
4
Comments over time
Weekly arrivals, stacked by stance.
Posted Apr 30, 2026Deadline Jun 30, 2026
May 4May 18Jun 1Jun 15Jun 29
Support19Oppose70Other5
Support × commenter type
How each type splits across stance.
Support
Oppose
Other
Individual
20%
75%
5%
Advocacy
25%
50%
25%
Business
0%
100%
0%
Issues raised
The docket's canonical issues. Select one to browse its comments.
Patient testimonial of efficacy24
Patient experience with tavneos18
Patient experience and efficacy17
Patient safety and efficacy14
Patient experience with avacopan12
Retain drug market availability10
Patient quality of life7
Patient safety and access5
Risk-benefit of continuing treatment5
Withdrawal of drug approval5
Position map
Who stands where on each issue?
Every non-silent position is backed by an excerpt from the comment.
Issues shown
Uncheck an issue to choose another.
| Organization | Patient experience with avacopan | Patient quality of life | Patient safety and access | Oppose withdrawal of tavneos | Retain drug market availability |
|---|---|---|---|---|---|
Vasculitis Foundation Canada AdvocacyOppose Jon Stewart, President of the Vasculitis Foundation Canada, opposes the proposed withdrawal of Avacopan for GPA and MPA | · | · |
3 organization-typed comments could not be identified.
Comments
Explorer
Every mirrored comment — filter by stance, campaign, or issue.
Filter:
- Jun 18, 2026Comment from National Kidney FoundationSupportAdvocacy📎 Attachment
The National Kidney Foundation (NKF) supports the proposal to provide Amgen (ChemoCentryx, Inc.) with an opportunity for a hearing regarding the potential withdrawal of TAVNEOS approval. While not taking a position on the merits of the evidence, the organization emphasizes the need for a transparent, fair process and clear communication for patients and clinicians.
Read comment → - Jun 9, 2026Comment from Vasculitis FoundationOtherAdvocacy📎 Attachment
The Vasculitis Foundation, a patient-focused nonprofit, states that it does not take a definitive position on whether the FDA should proceed with the withdrawal of TAVNEOS. Instead, they urge the FDA to ensure the final benefit-risk determination fully incorporates patient perspectives, accounts for the risks of existing alternatives, and considers regulatory tools like updated labeling before deciding on withdrawal.
Read comment → - Jun 1, 2026Comment from Amgen Inc.OpposeBusiness📎 Attachment
Amgen, the parent company of ChemoCentryx, opposes the FDA's proposal to withdraw approval of TAVNEOS (avacopan). They argue that the drug's benefits outweigh its risks for patients with rare diseases and request a hearing to present additional data and studies.
Read comment → - May 30, 2026Comment from AIGM IncOpposeBusiness📎 Attachment
AIGM Inc., an AI-driven drug discovery company, opposes the proposed withdrawal of TAVNEOS (avacopan) from the market. They argue that the drug's hepatotoxicity is a result of its specific physicochemical properties rather than a liability of the C5aR1 target, and they recommend label restrictions instead of a full withdrawal.
Read comment → - May 15, 2026Comment from AnonymousSupportIndividual
A practicing rheumatologist supports the FDA's proposal to withdraw approval of TAVNEOS (avacopan) due to concerns over its real-world effectiveness and potential risks like hepatotoxicity. The commenter argues that the original trial data were unreliable and that the drug should be re-evaluated in a modern, well-controlled Phase 3 trial before being reintroduced to the market.
Read comment →