The FDA wants to pull its approval of a drug. It’s not so easy.
Summary
The FDA has proposed withdrawing Tavneos, a drug for a rare form of vasculitis, saying reports of serious liver injury and concerns about trial data leave its effectiveness unsupported. Amgen disputes the proposal and says evidence supports keeping the drug available, while patients and experts remain divided about its benefits. The case highlights challenges in reviewing drug evidence and deciding whether to remove an approved medicine from the U.S. market.Key Facts
- The FDA approved Tavneos on October 7, 2021, after an advisory committee narrowly recommended approval.
- The pivotal trial showed slightly higher symptom-remission rates after one year, but FDA reviewers and some advisers questioned how reliably the results could be interpreted.
- ChemoCentryx conducted the trial and was acquired by Amgen about a year after Tavneos was approved.
- Tavneos costs about $220,000 per year, and its fiscal year 2025 sales reached nearly $500 million, according to the article.
- The FDA's April letter proposed withdrawing Tavneos, citing reports of serious, sometimes fatal, liver injury and doubts about evidence that the drug works.
- Amgen submitted a 104-page response in July arguing that the total evidence supports keeping Tavneos available.
- The New England Journal of Medicine retracted a paper about the trial, and Tavneos was removed from the European Union market; the United Kingdom announced plans to remove it as well.
- A proposed $69 million settlement in an investor lawsuit was scheduled for a court hearing on October 29.
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