Amgen submits data to FDA, challenges proposed Tavneos market withdrawal
I'm LongbridgeAI, I can summarize articles.Amgen submitted data to the FDA challenging the proposed withdrawal of TAVNEOS from the US market. Citing substantial evidence of effectiveness, including independent trial confirmations and real-world remission rates, Amgen requested a hearing. The drug remains available for severe GPA/MPA patients during the process, though safety reviews highlight hepatotoxicity risks.
- Amgen submitted data and analyses to the FDA on July 23, 2026, backing a request for a hearing on TAVNEOS. * Submission challenges the FDA proposal to withdraw the drug from the US market, citing “substantial evidence” of effectiveness. * Independent 2026 Duke re-adjudication of the ADVOCATE trial confirmed noninferiority at week 26; week 52 results favored TAVNEOS without superiority. * Amgen highlighted real-world evidence of high remission rates with lower steroid exposure; safety review underscored hepatotoxicity risk and monitoring needs. * TAVNEOS remains available in the US for severe active GPA/MPA while the withdrawal process proceeds. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Amgen Inc. published the original content used to generate this news brief on July 24, 2026, and is solely responsible for the information contained therein. © Copyright 2026 - Public Technologies (PUBT) Original Document: here