FDA Seeks Tavneos Withdrawal Amid Data Manipulation Concerns
The US Food and Drug Administration is attempting to withdraw its approval for Tavneos, pointing to manipulated trial data, serious liver injury risks, and a lack of substantial evidence.
Radwan AbdulhadiEditor and technology writer
The Approval and Rise of Tavneos
In May 2021, the US Food and Drug Administration released a lengthy briefing document regarding an experimental medication designed to treat a rare autoimmune form of vasculitis that frequently damages the kidneys and lungs. The agency sought input from an independent advisory committee to determine if the treatment offered meaningful improvements over existing therapies.
The study, conducted by California biotechnology firm ChemoCentryx, showed that participants had slightly higher rates of symptom remission after a year, but the FDA noted the study's design was suboptimal. Despite the interpretive challenges and questions raised by advisory committee members, the committee narrowly recommended approval, and the FDA greenlit the drug on October 7, 2021.
A year following the approval, Amgen acquired ChemoCentryx. The medication, marketed under the name Tavneos, commands a price of $220,000 per year according to Drugs.com, and generated nearly half a billion dollars in sales during fiscal year 2025.
Uncovered Data Manipulation and Regulatory Fallout
The financial success of Tavneos unfolded despite a long-running investor lawsuit, which uncovered what the FDA now believes is evidence that ChemoCentryx employees manipulated data in the pivotal trial submitted to the agency. In April, the FDA issued a letter proposing the withdrawal of Tavneos from the US market, citing reports of serious and sometimes fatal liver injury alongside arguments that the drug lacks substantial evidence of efficacy.
These revelations triggered global actions. The New England Journal of Medicine retracted a paper describing the clinical trial, and Tavneos was taken off the market in the European Union. The United Kingdom also announced plans to remove the product from its market, while legal proceedings advanced regarding a proposed $69 million settlement for the ongoing investor lawsuit.
Patient Impact and the Need for Alternatives
The condition Tavneos aims to treat is ANCA-associated vasculitis, or AAV, an umbrella term for rare diseases where the immune system attacks its own blood vessels. Patients are immediately started on high doses of steroids to reduce inflammation, which can quickly lead to organ failure in the kidneys and lungs.
While steroids are effective, they come with severe side effects, including rapid weight gain, emotional volatility, sleep disturbances, and nightmares. Tavneos was developed to replace or reduce the dependence on these steroids over months or years of treatment.
Industry Defense and Expert Debate
Amgen has pushed back against critics, insisting that the drug works as advertised regardless of how the initial data was handled. In July, the company submitted a 104-page document to the FDA asserting that the totality of the evidence supports the continued availability of Tavneos.
Some academic experts and patients continue to support the medication as an important therapeutic option. However, regulatory experts note that the saga highlights systemic challenges within the FDA regarding the regulation of drugs with uncertain efficacy, raising questions about safeguards for drug approvals derived from smaller companies.
Sources
- Ars TechnicaThe FDA wants to pull its approval of a drug. It’s not so easy.
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