WashingtonTavneos was approved on manipulated data, US regulators say.
Tavneos, meant to reduce steroid use, sold nearly $500 million in fiscal 2025.
A shareholder suit’s report says employees unblinded the data, then reassessed chosen patients, and ChemoCentryx did not tell the regulator.
Amgen told the regulator in July that the totality of the evidence supports continued availability.
The regulator’s April withdrawal proposal, citing liver injuries, awaits a decision, and the EU has pulled the drug.
How each outlet framed it
- Ars Technica leans critical
- traces the 2021 approval to a briefing that doubted the study, then asks whether patients should keep access to the drug
Sources: Ars Technica