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 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.

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.

An individual patient who uses Tavneos for treatment expresses strong support for keeping the drug on the market. They argue that the drug is a "life saver" and advocate for the agency to consider real-life patient outcomes over trial data.

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 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.