Comment from Sarah Jones

To the Dockets Management Staff and the Director of the Center for Drug Evaluation and Research: My name is Sarah Jones. I am a person living with ANCA-associated vasculitis, and I am writing today as a patient — as someone who has lived inside this disease, not around it. While I am not eligible to take Tavneos, I am grateful it exists. And I am asking you not to remove it from the market. What this disease looks like: People with vasculitis are often diagnosed at the point the disease is already damaging organs. Treatment is swift and intense — the goal is to stop the escalation. Once on medications, many of us experience flares that require additional treatment to halt the disease again. Tavneos has a place in both moments. Real-world studies confirm it is effective. For many people, it offers something our other options have not — the ability to reduce steroids, protect kidney function, and return to something closer to a life. The reality of living with this disease is that even when it is quiet, it is a constant and unwelcome companion. The damage done before diagnosis — to kidneys, lungs, sinuses, nerves — does not reverse. We live with it. What we hope for, and wait for, are treatments that are more targeted and improve our quality of life. That is what Tavneos has been for the people it works for. We understand what our medications cost us: I am not talking about price. Prednisone — readily available, FDA-approved, comes with a list of consequences that reshapes a person’s life. Long-term use causes: •Osteoporosis and avascular necrosis (bone death) •Hyperglycemia and steroid-induced diabetes •Severe weight gain and changes in body composition •Hypertension and increased cardiovascular risk •Cataracts and glaucoma •Adrenal suppression — the body loses its ability to produce cortisol naturally •Increased susceptibility to serious infection •Mood changes, agitation, and psychiatric effects •Skin thinning, easy bruising, and poor wound healing •Muscle weakness These are not rare complications. They are the reality of most of the ANCA vasculitis community. A medication that allows people to reduce or avoid long-term steroid use is not a luxury. It is a meaningful reduction in cumulative harm. And prednisone is not the only treatment with a cost. My personal experience with medication informs my position that all of our medications carry significant risk, and Tavneos is an important treatment option. •Imuran left me hypoxic for a week causing permanent hippocampal atrophy. •Rituximab caused my throat to close and eventually led to serum sickness. •CellCept caused rapid liver toxicity. •Methotrexate caused severe rashes. The side effects of our treatments are not footnotes. They are a part of our daily lives. Option matters. That is exactly why removing an option is unconscionable. People with ANCA vasculitis do not have the luxury of declining a treatment because it is hard. We take what works, we monitor carefully, and we live with the tradeoffs — because the alternative is organ failure and death. To take away an option with nothing to replace it is not a safety decision. It is a harm. What I am asking: The FDA has tools available. Amgen submitted a label update in 2024 to add vanishing bile duct syndrome as a serious adverse reaction. That update is still pending. Use it. Require enhanced monitoring. Make sure every prescriber and every person starting Tavneos understands the risks clearly. Those are the right responses to a post-market safety concern. Removal is not. We already have too few treatments for this disease. Every option we have was hard won. I have spent years watching people in my community fight for access, fight for diagnosis, fight to be believed by the medical system — and fight to stay on medications that were keeping them alive. I am asking you not to make that fight harder. Please keep Tavneos available. Update the label. Let the people who need it and their physicians make this decision together. Respectfully submitted, Sarah Jones, MPA, MS Strategic Design Person living with ANCA-associated vasculitis