At a Glance
- Company: Amgen
- Drug: Tavneos (avacopan)
- Issue: Disagreement over trial data and benefit-risk profile
- Focus area: ANCA-associated vasculitis
- Next steps: FDA hearing and independent review
What happened?
The FDA has raised concerns about how key Tavneos trial data were re-adjudicated and has asked Amgen to voluntarily withdraw the drug from the US market. Amgen, which acquired Tavneos through ChemoCentryx, says it does not intend to withdraw the medicine and still believes the drug has a favourable benefit-risk profile.
Why does it matter?
Tavneos is used in rare, serious ANCA-associated vasculitis, where treatment options are limited. The dispute matters because the FDA is questioning both the integrity of the efficacy dataset and the drug’s liver-safety profile, which could affect whether patients continue to have access to it.
Who’s behind it?
Amgen now owns Tavneos after buying ChemoCentryx, the original developer. The FDA is reviewing the drug’s approval basis and has signalled concern about both the ADVOCATE trial analysis and hepatotoxicity reports.
How was it achieved?
Tavneos was approved mainly on the ADVOCATE Phase 3 trial, which showed remission benefits at 26 and 52 weeks. The current controversy centres on the FDA’s view that the re-adjudication of primary endpoint results for nine patients may have been problematic, alongside later safety signals involving liver injury.
What’s next?
A hearing is expected to include findings from an independent review of the trial data, which could shape Tavneos’ future in the US. Amgen says it is working with the FDA on a path forward while keeping patient safety and access in mind.