ChemoCentryx, Inc.; Proposal To Withdraw Approval of New Drug Application for TAVNEOS (Avacopan) Capsule, 10 Milligrams; Opportunity for a Hearing

A patient who uses Tavneos to treat a rare autoimmune disease expresses strong support for the medication, stating it saved her life and has kept her condition stable. She opposes the proposal to withdraw approval of the drug.

A patient with Granulomatosis with Polyangitis (GPA) shares their personal experience of successfully using Tavneos to improve their kidney function and taper off corticosteroids. They strongly urge the FDA to maintain the drug's approval, citing its significant impact on their quality of life.

Jon Stewart, President of the Vasculitis Foundation Canada, opposes the proposed withdrawal of Avacopan for GPA and MPA vasculitis. The organization argues that Avacopan is a significant advancement in treatment that reduces reliance on toxic glucocorticoids and highlights positive real-world evidence of its efficacy.

A private individual who is the daughter of a patient expresses strong opposition to withdrawing the drug Tavneos from the market. They argue that the medication saved their mother's life and restored her kidney function following a diagnosis of Pauci-immune glomerulonephritis.

Anna Castella, a long-term patient with Granulomatosis with polyangiitis (GPA), opposes the proposal to withdraw approval of TAVNEOS (avacopan). She argues that the drug is the first specific treatment for her disease and that patients should have the option to weigh its benefits against its risks.

Philip Steelman, a patient with Microscopic Polyangiitis, urges the FDA not to withdraw approval of Tavneos. He argues that the medication has been a "miracle" for his health and that its therapeutic benefits for thousands of patients outweigh the risks of liver injury.

A patient who suffered from severe ANCA Vasculitis and kidney failure argues against the withdrawal of the TAVNEOS (Avacopan) application. The commenter shares their personal experience of successful treatment with the drug, noting it allowed them to titrate off steroids and discontinue dialysis.