The US Food and Drug Administration is seeking to withdraw approval for Tavneos, a drug used to treat a rare autoimmune form of vasculitis that can damage the kidneys and lungs. The agency says evidence uncovered through an investor lawsuit indicates that employees of ChemoCentryx manipulated data from the pivotal clinical trial submitted for approval.
The FDA had expressed reservations about Tavneos before approving it. In a May 2021 briefing document, the agency said the study’s design made its results difficult to interpret. Patients receiving the drug appeared to have slightly higher rates of symptom remission after one year, but one advisory committee member said the treatment’s effect was not adequately verified by the study.
Despite those concerns, the advisory committee narrowly recommended approval. The FDA approved Tavneos on October 7, 2021, and the drug subsequently entered clinical use. Some patients and physicians viewed it as a potentially useful option because it could reduce reliance on steroids, which can be effective but may cause serious side effects.
ChemoCentryx was acquired by Amgen a year after the approval. Tavneos now costs about $220,000 per year, according to Drugs.com, and its sales reached nearly half a billion dollars in fiscal year 2025.
In April, the FDA issued a letter proposing that Tavneos be removed from the US market. The agency cited reports of serious, sometimes fatal, liver injuries and argued that the drug no longer has substantial evidence demonstrating that it works. The proposed withdrawal raises a difficult question for patients who may still depend on continued access to the treatment.
Sources: Ars Technica.