Amgen submits new data to challenge FDA's proposal to withdraw Tavneos

Amgen

24/07/2026 14:43

    July 24 (Reuters) - Amgen AMGN.O said on Friday it submitted new evidence to the FDA on July 23 as it seeks a hearing to challenge the proposed withdrawal of its rare-disease drug Tavneos from the U.S. market.
The U.S. Food and Drug Administration in April proposed withdrawing the drug, which treats a rare autoimmune disease that damages blood vessels, citing a lack of proven effectiveness and false statements in its original marketing application.    

Here are some details:
Amgen said it strongly disagrees with the FDA and that its submission includes more than 70 real-world studies involving over 2,200 patients supporting the drug’s effectiveness and safety.

        The drug developer said the Duke Clinical Research Institute, which it 
        had commissioned
         to independently review the pivotal trial, found Tavneos matched a steroid treatment regimen at 26 and 52 weeks, although it did not reproduce the original finding of superiority at 52 weeks.
      

        The FDA did not immediately respond to a Reuters request for comment.
      
The health regulator in March had separately identified 76 cases of serious liver injury linked to Tavneos, including eight deaths and seven cases of a rare condition that can cause permanent liver damage.

        In June, Europe's drug regulator recommended revoking the drug's approval, citing unreliable study data.
Tavneos treats severe active ANCA-associated vasculitis, a rare disease that inflames blood vessels and can damage organs including the kidneys and lungs.
The FDA said in April that Tavneos would remain on the U.S. market unless Amgen removes it or the FDA commissioner orders its withdrawal.

 (Reporting by Kunal Das in Bengaluru; Editing by Sahal Muhammed)
 ((Kunal.Das2@thomsonreuters.com;))