Comment from Vasculitis Foundation
AnonymousOtherAdvocacy
Summary: 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.
Docket No. FDA-2026-N-1321 Comment on the Proposed Withdrawal of NDA 214487 for TAVNEOS (Avacopan); Request for a Full Benefit-Risk Determination That Incorporates Patient Perspectives and the Risks of Available Alternatives