ChemoCentryx, Inc.; Proposal To Withdraw Approval of New Drug Application for TAVNEOS (Avacopan) Capsule, 10 Milligrams; Opportunity for a Hearing
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- 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
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| 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.
Explorer
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- Jun 29, 2026Comment from AnonymousOtherIndividualRead comment →
- Jun 18, 2026Comment from AnonymousOpposeIndividual
A patient who experienced positive outcomes from Tavneos argues against withdrawing its approval. The commenter suggests that the observed liver injuries might be caused by the patient's underlying condition (EGPA vasculitis) rather than the drug itself.
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 20, 2026Comment from Ron BlackOpposeIndividual
A patient currently using Tavneos for ANCA Vasculitis expresses strong opposition to withdrawing the drug's approval. They argue that the risk of a disease flare and subsequent kidney damage far outweighs the potential risk of liver side effects, and they note that their medical team supports continuing the treatment.
Read comment →
