Amgen has engaged Duke to independently reevaluate Tavneos data

Amgen has engaged Duke University to independently reevaluate the clinical data for Tavneos (avacopan), following concerns raised by the FDA regarding the assessment of primary endpoint results in the phase 3 ADVOCATE trial. The FDA requested that ChemoCentryx, the original developer of Tavneos, withdraw the drug from the U.S. market in January 2026, citing issues with how 9 of the 331 patients were reassessed for the trial’s primary endpoint and concerns about the drug’s benefit-risk profile, particularly related to concerns about hepatotoxicity. Amgen, which acquired ChemoCentryx in 2022, has declined to remove Tavneos from the market and is working with the FDA to determine a path forward.

The ADVOCATE trial demonstrated that Tavneos was noninferior to prednisone in achieving remission at week 26 and superior in sustaining remission at week 52. Amgen maintains that the clinical data and real-world evidence support the drug’s favorable benefit-risk profile, especially given the limited treatment options for patients with severe active ANCA-associated vasculitis. The company is also conducting postmarketing studies and real-world observational research to further evaluate the drug’s safety and effectiveness.

Amgen has emphasized its commitment to patient safety and transparency, including ongoing monitoring of hepatotoxicity risks and other adverse events. Patients and healthcare providers are encouraged to report any suspected adverse events to Amgen or the FDA. The outcome of the FDA’s review and the independent reevaluation by Duke will likely influence the drug’s future regulatory status and market availability.