Amgen submits data to FDA, challenges proposed Tavneos market withdrawal

Amgen said the safety review underscored hepatotoxicity risk and the need for monitoring. TAVNEOS remains available in the US for severe active GPA/MPA while the withdrawal process proceeds.

Amgen said it submitted data and analyses to the FDA on July 23, 2026, backing a request for a hearing on TAVNEOS. The submission challenges the FDA proposal to withdraw the drug from the US market, citing “substantial evidence” of effectiveness.

Amgen said an independent 2026 Duke re-adjudication of the ADVOCATE trial confirmed noninferiority at week 26, while week 52 results favored TAVNEOS without superiority. The company also highlighted real-world evidence of high remission rates with lower steroid exposure.