AMGN · News · 20260901N
Tavneos Regulatory Withdrawal Risk
AMGEN INC · 2026-09-01 · Importance 47 · Surprise 60 · In source text
The United Kingdom’s medicines regulator suspended Amgen’s Tavneos for new patients after finding unreliable data in the drug’s main study. The regulator said the trial could no longer establish Tavneos’s efficacy or show that its benefits outweighed its risks. UK approval is expected to be revoked on March 1, 2027, while current patients may continue treatment for six months during consideration of alternatives. The action follows similar European Commission measures and a proposed U.S. FDA withdrawal linked to serious liver injuries.
Key facts
- The UK regulator plans to revoke approval of Tavneos on March 1, 2027. source
- The UK's medicines regulator has suspended Amgen's Tavneos for new patients due to unreliable data from its main study. source
- Current patients on Tavneos in the UK can continue treatment for six months while alternatives are considered following the suspension for new patients. source
Impact estimates
| metric | direction | stage | expected | basis |
|---|---|---|---|---|
| revenue | negative | probable | — | The UK regulator plans to revoke approval of Tavneos on March 1, 2027. |
| revenue | negative | probable | — | The UK's medicines regulator has suspended Amgen's Tavneos for new patients due to unreliable data from its main study. |