FDA Yanks Drug Approval: Lies and Lies in Medicine's Pipeline?
Published Date: 4/30/2026
Notice
Summary
The FDA wants to take back its approval of the drug TAVNEOS, made by ChemoCentryx, because new info shows it might not work as promised and some facts in the application weren’t true. ChemoCentryx can ask for a hearing by June 1, 2026, to defend their drug. This could affect patients using TAVNEOS and might shake up the company’s plans and finances.
Free Policy Watch
New rules are filed every week. Most people never see them.
Pick a topic. PRIA watches every federal rule and tells you when one hits your household.
Pick a topic to get started
Analyzed Economic Effects
3 provisions identified: 1 benefits, 1 costs, 1 mixed.
FDA Proposes Withdrawal of TAVNEOS Approval
The FDA is proposing to withdraw approval of TAVNEOS (avacopan) capsule, 10 mg, which the agency originally approved on October 7, 2021 for adjunctive treatment of adult patients with severe active ANCA-associated vasculitis. The agency's grounds are that new information shows manipulated study data and untrue statements of material fact, so there is a lack of substantial evidence that the drug is effective under the labeled conditions.
Postmarket Safety Signals: Liver Risks
FDA identified hepatotoxicity as a key safety risk for avacopan and noted serious and sometimes fatal hepatotoxicity cases reported after approval. Recent postmarketing safety reports also suggest avacopan may be associated with vanishing bile duct syndrome (VBDS), an unexpected serious adverse event.
Hearing and Comment Deadlines Set
ChemoCentryx (the applicant) may request a hearing on the proposed withdrawal by June 1, 2026, and must submit all data and analyses supporting a hearing request by June 29, 2026. Other interested parties may submit electronic or written comments by June 29, 2026.
Your PRIA Score
Personalized for You
How does this regulation affect your finances?
Sign up for a PRIA Policy Scan to see your personalized alignment score for this federal register document and every other regulation we track. We analyze your financial profile against policy provisions to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Take It Personal
Get Your Personalized Policy View
Take the PRIA Score to see how policy affects your household, then upgrade to PRIA Full Coverage for year-round monitoring.
Already have an account? Sign in