FDA Yanks TAVNEOS Drug Approval Over Lies and Doubts
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 impact the company’s sales and future plans.
Analyzed Economic Effects
3 provisions identified: 0 benefits, 3 costs, 0 mixed.
FDA Proposes Withdrawal of TAVNEOS Approval
The FDA is proposing to withdraw approval of the new drug application (NDA 214487) for TAVNEOS (avacopan) held by ChemoCentryx/Amgen because new information indicates the drug lacks substantial evidence of effectiveness and the application contains untrue statements of material fact. The company may request a hearing by June 1, 2026 and submit supporting data by June 29, 2026; others may submit comments by June 29, 2026.
Postmarket Liver Safety Concerns Raised
FDA notes that hepatotoxicity was identified as a key safety risk in the original NDA review and that serious and sometimes fatal cases of hepatotoxicity have been reported postmarketing; recent reports also suggest a possible association with vanishing bile duct syndrome (VBDS). FDA states that because there is now a lack of substantial evidence of benefit, there is no demonstrated benefit to balance these liver risks for TAVNEOS.
Data Manipulation Finding Threatens Company Sales
FDA found that unblinded sponsor personnel readjudicated ADVOCATE study data after database lock in a way that changed the primary endpoint from not statistically significant to statistically significant, and that the NDA contained untrue statements about database lock and analyses. FDA says these findings support withdrawing approval, which could harm ChemoCentryx/Amgen's sales and future plans for TAVNEOS.
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