ChemoCentryx, Inc.; Proposal To Withdraw Approval of New Drug Application for TAVNEOS (Avacopan) Capsule, 10 Milligrams; Opportunity for a Hearing

Jon Stewart, President of the Vasculitis Foundation Canada, opposes the proposed withdrawal of Avacopan for GPA and MPA vasculitis. The organization argues that Avacopan is a significant advancement in treatment that reduces reliance on toxic glucocorticoids and highlights positive real-world evidence of its efficacy.

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.

A healthcare provider (likely a physician) argues against withdrawing approval for TAVNEOS, stating that the drug is a life-saving treatment for a difficult-to-control disease. They contend that while liver concerns should be monitored, removing the medication from the market would cause more harm than protection for patients.

A healthcare worker and patient with GPA/WG argues that avacopan should remain on the market as a necessary alternative to long-term prednisone. They contend that while the drug may not be suitable for every individual, it provides effective inflammation control and that the decision to use it should remain between the patient and their provider.