TAVNEOS approval withdrawal proposed
- Sponsor
- ChemoCentryx, Inc.
- Drug
- TAVNEOS · avacopan
FDA proposes to withdraw approval of ChemoCentryx's TAVNEOS (avacopan) due to lack of substantial evidence and material misstatements in the application.
What this means
TAVNEOS is an oral drug that treats a rare autoimmune disease by blocking a specific immune system protein involved in inflammation. The FDA announced plans to pull the drug from the market, saying the original approval lacked sufficient proof of effectiveness and contained significant errors in the application. This could leave patients currently on TAVNEOS needing to switch treatments if the withdrawal goes through, though the company may challenge the decision.
From the source
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Reproduced from Federal Register — FDA Advisory Committees · view original · public domain or open-licensed government work