Amgen asks FDA for a hearing to contest proposed withdrawal of Tavneos

Amgen said it submitted data and analyses to the FDA on July 23, 2026, requesting a hearing on the agency's proposal to withdraw approval of TAVNEOS (avacopan). The FDA proposed the withdrawal earlier in 2026, citing a lack of substantial evidence of effectiveness. Amgen argues that the submission shows the drug meets the statutory standard, and it wants a hearing before any final decision on removing the product from the U.S. market.

• Amgen submission to FDA dated July 23, 2026
• Amgen requested a formal hearing before any withdrawal decision
• FDA's proposal to withdraw approval was published in April 2026
• Amgen states the drug meets the substantial-evidence standard
• The product is a rare-disease medicine, not part of Amgen's largest franchises