On January 16, 2026, the FDA requested Amgen (via ChemoCentryx) to voluntarily withdraw Tavneos from the U.S. market due to concerns over re-adjudication of primary endpoint data for 9 out of 331 patients in the ADVOCATE trial and hepatotoxicity risks.
Amgen informed the FDA on January 28, 2026, that it would not withdraw the drug, citing confidence in its effectiveness and favorable benefit-risk profile based on clinical data and real-world evidence.
Tavneos, approved in 2021 for severe active ANCA-associated vasculitis (GPA/MPA), remains available to patients.
The Phase 3 ADVOCATE trial showed Tavneos noninferior to prednisone at week 26 remission (72.3% vs 70.1%) and superior at week 52 (65.7% vs 54.9%).
Tavneos generated $152 million in Q4 2025 and $459 million for the full year, with projections of $600 million in 2026.
Amgen is in ongoing discussions with the FDA and continues post-marketing studies and pediatric trials.