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

A community rheumatologist argues against the withdrawal of approval for TAVNEOS (Avacopan), citing its significant clinical benefits for patients with severe vasculitis who failed standard treatments. The commenter acknowledges the risk of liver toxicity but suggests it can be managed through closer monitoring.

A patient who experienced positive outcomes from Tavneos argues against withdrawing its approval. The commenter suggests that the observed liver injuries might be caused by the patient's underlying condition (EGPA vasculitis) rather than the drug itself.

Dee, a patient, shares a positive personal experience with Tavneos (avacopan), stating that the medication has helped them achieve remission with minimal side effects. They argue against the withdrawal of the drug's approval by highlighting its effectiveness as a steroid-sparing treatment and its success in managing their condition.

A parent is requesting that the FDA not withdraw the approval of TAVNEOS (Avacopan). They argue that the medication has been life-saving for their daughter and would be a significant regression to use steroids instead.

A rheumatologist who treats patients with ANCA-associated vasculitis argues against withdrawing the approval of TAVNEOS (Avacopan). The commenter notes that while the drug has side effects requiring monitoring, it is effective in real-world practice and provides a necessary option for patients with limited treatment choices.

A patient with microscopic polyangiitis (MPA) shares their personal experience of how Tavneos allowed them to successfully taper off prednisone, which caused severe side effects. They urge the agency not to withdraw the drug from the market because it significantly improved their quality of life and health.

A patient with Granulomatosis with polyangiitis (GPA) argues against the withdrawal of Avacopan (TAVNEOS) approval, stating that the medication saved their life and has been well-tolerated without side effects. They express concern that removing the drug from the FDA's approved list would jeopardize their health and remission.

A patient with ANCA-associated vasculitis and a retired scientist opposes the withdrawal of Avacopan, arguing that it is a vital steroid-sparing treatment that improves kidney function and reduces long-term complications. The commenter suggests that instead of a market withdrawal, the FDA should focus on strengthening liver monitoring protocols and labeling to manage hepatotoxicity risks.