Comment from National Kidney Foundation

June 18, 2026 The Honorable Kyle A. Diamantas, J.D. Acting Commissioner of Food and Drugs U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 cc: Dr. Michael Davis, Acting Center Director, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration Dr. Sarah Ibrahim, Acting Deputy Center Director for Regulatory Programs, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration Re: Docket No. FDA–2026–N–1321; ChemoCentryx, Inc.; Proposal to Withdraw Approval of New Drug Application for TAVNEOS (Avacopan) Capsule, 10 Milligrams; Opportunity for a Hearing Dear Acting Commissioner Diamantas, On behalf of the National Kidney Foundation (NKF) and the thousands of Americans living with anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV), we write to express our belief that Amgen (ChemoCentryx, Inc.) should be afforded the opportunity for a hearing consistent with FDA’s established process. NKF appreciates the opportunity to comment on the Food and Drug Administration’s notice proposing to withdraw approval of TAVNEOS (avacopan) and providing the applicant an opportunity for a hearing. NKF takes seriously FDA’s responsibility to ensure that approved therapies are supported by reliable evidence of safety and effectiveness. Patients and providers must be able to trust that therapies available on the market meet FDA’s standards. At the same time, when questions arise regarding an approved therapy, particularly one used to treat a serious and complex disease, patients and clinicians deserve a transparent, orderly process that allows the evidence and relevant facts to be fully considered. For that reason, NKF believes Amgen should be afforded the opportunity for a hearing. NKF is not taking a position on the underlying evidence, the merits of the allegations described in the notice, or the ultimate outcome of the proceeding. Rather, our concern is that any decision affecting availability of this therapy be made through a fair and complete process that provides clarity to patients, caregivers, and providers. AAV can have serious kidney implications, and treatment decisions are highly individualized. Patients and providers should not be left without clear information, viable treatment pathways, or appropriate transition planning. If FDA proceeds toward withdrawal, NKF urges the Agency to ensure timely communication to patients and clinicians, clear guidance on treatment continuity and discontinuation, and consideration of how patients currently receiving the therapy can be safely managed. At the same time, NKF does not support continued market availability of a therapy if, after a full and fair review, the evidence does not demonstrate efficacy or an acceptable benefit-risk profile. Protecting patients requires both access to meaningful treatment options and confidence that those options meet rigorous scientific standards. NKF appreciates FDA’s commitment to patient safety, scientific integrity, and transparency. Sincerely, Dr. Jesse Roach, MD Senior Vice President, Government Relations The National Kidney Foundation