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

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.

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.

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.

A patient living with GPA expresses strong opposition to withdrawing the approval of TAVNEOS (Avacopan). The commenter argues that the drug is a vital treatment option that provides better outcomes than previous medications and that removing it would leave patients with fewer safe choices.

A patient living with ANCA-associated vasculitis opposes the withdrawal of TAVNEOS (Avacopan), sharing their personal experience of how the drug successfully improved their kidney function and allowed them to taper off steroids. They argue that real-world evidence shows the drug is effective and that removing it would deprive other patients of a life-altering treatment option.

A patient with GPA Vasculitis shares their positive personal experience with Tavneos (avacopan), stating that the medication has significantly improved their quality of life and put their condition into remission. They argue against the withdrawal of the drug's approval, describing it as life-saving for those with the condition.

A family member of a patient with ANCA-associated vasculitis opposes the withdrawal of approval for TAVNEOS (avacopan). They argue that the medication has significantly improved their mother's quality of life and provided a necessary alternative to high-dose steroids.

Timothy Hahn, a patient's spouse, opposes the withdrawal of TAVNEOS approval because the medication significantly improved his wife's quality of life and health. He argues that the drug's risks (hepatotoxicity) appear to be specific to certain demographics and can be managed through enhanced monitoring and updated prescribing information rather than a total market withdrawal.

Sarah Jones, a patient living with ANCA-associated vasculitis, opposes the withdrawal of TAVNEOS from the market. She argues that the drug provides a critical treatment option that reduces the need for harmful steroids and suggests that the FDA should instead update the drug's label and require enhanced monitoring.