● Covered by 1 source · 1 reportMedium impact1 negative
FDA Proposes Withdrawal of Tavneos Drug Approval Citing Data Manipulation and Liver Injury
Key points
- FDA proposes withdrawing Tavneos approval.
- Cites data manipulation in original trial by ChemoCentryx.
- Reports of serious, sometimes fatal, liver injury.
- Tavneos was approved in 2021 despite initial FDA concerns.
FDA Initiates Withdrawal Process for Tavneos
The US Food and Drug Administration (FDA) issued a letter in April proposing the withdrawal of Tavneos from the US market. Tavneos is a medication for a rare autoimmune form of vasculitis. The FDA now argues that the drug lacks "substantial evidence" of efficacy and cites reports of serious, sometimes fatal, liver injury associated with its use.
Background of Initial Approval
In May 2021, the FDA had concerns about approving Tavneos due to the study's suboptimal design and difficulty interpreting results, despite participants showing slightly higher rates of symptom remission. An independent advisory committee narrowly recommended approval, which the FDA followed, greenlighting the drug on October 7, 2021. The drug, marketed by ChemoCentryx, subsequently generated nearly half a billion dollars in sales by fiscal year 2025 and led to Amgen's acquisition of ChemoCentryx.
Discovery of Data Manipulation
The FDA's current decision to propose withdrawal stems from evidence uncovered during an investor lawsuit. This lawsuit incidentally revealed that ChemoCentryx employees allegedly manipulated data in the pivotal trial submitted to the agency. This manipulation, combined with new safety concerns, forms the basis for the FDA's proposed action.
Impact and Cost
Tavneos, priced at $220,000 per year, has been in clinics since its approval. The proposed withdrawal could impact patients relying on the medication and has significant implications for Amgen, which acquired ChemoCentryx after the drug's initial approval and subsequent financial success.
✨ This summary was generated by AI from the outlets' reporting listed below. It is not independently verified and may contain errors — check the original sources. How BrevFeed works →
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Reporting from
The FDA has proposed withdrawing its approval for Tavneos, a drug for a rare autoimmune vasculitis, citing newly uncovered evidence of data manipulation in the original trial by ChemoCentryx and reports of serious liver injuries. This action comes after the drug was approved in 2021 despite initial FDA concerns and an advisory committee's narrow recommendation, leading to ChemoCentryx's acquisition by Amgen and significant sales.