Comment from Wright Deon

To Whom It May Concern: I am writing regarding TAVNEOS (avacopan) and the FDA’s consideration of withdrawing its approval. My mother has ANCA-associated vasculitis, a serious and potentially life-threatening autoimmune disease. Before TAVNEOS, our family lived with constant uncertainty about her health and future. Like many vasculitis patients, she faced the burden of severe disease, intensive treatments, and the significant side effects associated with long-term corticosteroid use. Since beginning treatment with TAVNEOS, the change in her health and quality of life has been remarkable. This medication has helped control her disease in ways that previous treatments could not. It has allowed her to regain stability, independence, and hope. Most importantly, it has given our family precious time with a mother, grandmother, and loved one whose life was profoundly impacted by vasculitis. I understand and respect the FDA’s responsibility to carefully evaluate both the safety and effectiveness of all medications. Patient safety must always remain a priority. At the same time, I ask that the experiences of patients and families who have directly benefited from TAVNEOS be given meaningful consideration during this review process. For patients living with ANCA-associated vasculitis, treatment options are limited. Many patients face serious complications from both their disease and the medications used to treat it. For some individuals, TAVNEOS has represented an important advancement by helping control disease activity while reducing reliance on high-dose steroids. This has truly been a lifeline for my mom, who is not able to tolerate high dose steroids. TAVNEOS, has been the only medication to help her. While I cannot speak to the scientific analyses under review, I can speak to what I have witnessed firsthand. TAVNEOS has made a significant difference in my mother’s life. It has helped her achieve a level of health and stability that we feared might never be possible. The possibility of losing access to this treatment is deeply concerning for our family and, I believe, for many others facing this devastating disease. I respectfully ask the FDA to carefully consider the experiences and outcomes of patients who have benefited from TAVNEOS before making a final decision regarding its availability. Thank you for your time, consideration, and commitment to serving patients. Sincerely, A Family Member of a Patient with ANCA-Associated Vasculitis