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

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 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.

The National Kidney Foundation (NKF) supports the proposal to provide Amgen (ChemoCentryx, Inc.) with an opportunity for a hearing regarding the potential withdrawal of TAVNEOS approval. While not taking a position on the merits of the evidence, the organization emphasizes the need for a transparent, fair process and clear communication for patients and clinicians.

The Vasculitis Foundation, a patient-focused nonprofit, states that it does not take a definitive position on whether the FDA should proceed with the withdrawal of TAVNEOS. Instead, they urge the FDA to ensure the final benefit-risk determination fully incorporates patient perspectives, accounts for the risks of existing alternatives, and considers regulatory tools like updated labeling before deciding on withdrawal.

Amgen, the parent company of ChemoCentryx, opposes the FDA's proposal to withdraw approval of TAVNEOS (avacopan). They argue that the drug's benefits outweigh its risks for patients with rare diseases and request a hearing to present additional data and studies.

AIGM Inc., an AI-driven drug discovery company, opposes the proposed withdrawal of TAVNEOS (avacopan) from the market. They argue that the drug's hepatotoxicity is a result of its specific physicochemical properties rather than a liability of the C5aR1 target, and they recommend label restrictions instead of a full withdrawal.