AMGN · News · 20260901N

Tavneos Withdrawal Risk

AMGEN INC · 2026-09-01 · Importance 47 · Surprise 60

The UK's medicines regulator suspended Amgen's Tavneos for new patients because unreliable data from the main study could no longer establish efficacy or a favorable benefit-risk balance. The regulator plans to revoke UK approval on March 1, 2027. Existing patients may continue treatment for six months while alternatives are considered. The action follows similar measures by the European Commission and a proposed U.S. FDA withdrawal, with the FDA also citing serious liver injuries.

Key facts

• The U.S. FDA has linked Tavneos to serious liver injuries. source
• The UK suspension of Tavneos follows similar actions by the European Commission and a proposed withdrawal by the U.S. FDA. source