Comment from Anonymous

To Whom It May Concern: I am submitting this comment as a patient living with granulomatosis with polyangiitis (GPA), a form of ANCA-associated vasculitis. I have been treated with Tavneos (avacopan) for more than three years. During that time, it has been an important part of my treatment plan and has had a meaningful impact on both my disease management and my quality of life. Before Tavneos, like many vasculitis patients, I faced the reality of long-term steroid treatment. While steroids can be effective, they come with significant physical and emotional costs. One of the greatest benefits of Tavneos for me has been the ability to successfully discontinue steroids while maintaining control of my disease. The improvement in my quality of life has been significant. I have more energy, greater day-to-day stamina, and a stronger ability to participate fully in my life. I work full-time in a demanding executive role, and being able to maintain my health has allowed me to continue contributing professionally and supporting my family. Most importantly, Tavneos has helped me show up for my children. Rather than spending my time managing the effects of disease activity or steroid-related side effects, I have been able to be present for the moments that matter most—supporting my daughters' activities, attending important events, traveling with my family, and simply participating in everyday life as a parent. I recognize and respect the FDA's responsibility to carefully evaluate the safety and effectiveness of approved medications. However, I encourage the Agency to consider the experiences of patients like me who have benefited from Tavneos in real-world practice. ANCA-associated vasculitis is a rare, serious, and potentially life-altering disease. Treatment decisions are highly individualized, and maintaining access to effective therapies gives patients and physicians the ability to choose the approach that best fits each person's circumstances. For me, Tavneos has been more than a medication. It has helped me reduce steroid exposure, maintain my health, continue my career, and be present for my family. I respectfully ask that these patient experiences be given meaningful consideration during your review. Thank you for the opportunity to share my experience. Sincerely, Patient with Granulomatosis with Polyangiitis (GPA)