Comment from Mitchell Pamella

In June, 2024 at the age of 66, I was diagnosed with Granulamatosis with Polyangitis ANCA Vasculitis. I was in acute kidney failure and thought my diagnosis was a death sentence. When I asked my nephrologist about treatments, she told me about the success of patients treated with Tavneos. I was encouraged, hopeful, and eager to get started on this medication. We discussed the success patients with GPA/MPA had in “quieting” their disease after taking Tavneos. I understood if I was a candidate for taking it I could potentially taper off of corticosteroids and reduce the risks of some of the adverse side effects caused by corticosteroids. My doctor also informed me of the risk for serious liver problems while taking Tavneos and said I would need frequent blood tests to monitor my liver functioning. I was eager and willing to start on Tavneos as soon as I could. On August 1, 2024, I started taking 30 mg of Tavneos twice a day. My doctors frequently monitored my lab work results, including kidney and liver tests. My kidney function improved from 14 eGFR at diagnosis to 60 eGFR months later. My liver tests remained normal throughout my course on Tavneos and remains normal. My physical condition progressively improved. I felt better. I was able to taper down the steroids and eventually stop them in January 2025. I continued taking Tavenos until January 31, 2026. Thankfully, my GPA is still currently quiet. My life now is different than prior to my diagnosis, especially the fatigue I feel from the disease and worry about the risk of infection or relapse. I feel strongly that my ability to take Tavneos was a significant factor in me having a better quality of life than if I had taken longer term steroids. I was able to taper off and avoid the many of the side effects of corticosteroids. I am grateful to the scientists who developed Avacopan/Tavneos. I believe that Tavneos aided me in achieving and maintaining relapse. I sincerely hope and strongly encourage the FDA to continue approval of Taveneos for treatment of ANCA Vasculitis with GPA and MPA. Thank you for your consideration.