Comment from Amanda Bauer

Docket No. FDA-2026-N-1321 for “ChemoCentryx, Inc.; Proposal to Withdraw Approval of New Drug Application for TAVNEOS (Avacopan) Capsule, 10 Milligrams; Opportunity for a Hearing.” I thank you for the opportunity to comment on the proposed removal of avacopan from the US market. I am a healthcare worker and I have been living with GPA/WG for 20 years. I recently tried avacopan and experienced intolerable side effects which led me to stop using the drug after about 8 weeks. While avacopan is not the right therapy for me, it provides effective control of inflammation and an alternative to the high-dose, long-term prednisone which has been a standard component of vasculitis therapy for decades and which comes with its own significant risks and side effect profile. As with any drug, each patient and their provider need to weigh the potential benefits versus the potential risks involved in taking avacopan. The risks were clearly communicated to me and a 24 hour pharmacy phone line dedicated specifically to avacopan was provided to me. The treatment options for the ANCA-associated vasculitides are frustratingly sparse. As with many diseases affecting limited patient populations, drug makers do not find it sufficiently profitable to advance the therapeutic options available to vasculitis patients. I urge the FDA to allow avacopan to remain on the market and keep the decision about whether avacopan is the right therapy for an individual between the patient and their provider. With proper communication between the patient and provider and frequent monitoring, avacopan can be a safe and effective component of treatment for ANCA-associated vasculitis. Thank you.