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.

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 private individual who is the caregiver for a patient with ANCA Vasculitis opposes the withdrawal of approval for TAVNEOS. They argue that the medication is a vital treatment for their relative, who cannot tolerate other standard treatments like high-dose steroids.

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.

A patient with Osteoporosis and ANCA-associated vasculitis opposes the withdrawal of Tavneos approval, arguing that the drug allows for significantly lower prednisone dosing. The commenter highlights the life-saving benefits of reducing prednisone for patients with pre-existing conditions like osteoporosis and diabetes.