UK suspends Tavneos for new patients over trial data concerns

Britain’s Medicines and Healthcare products Regulatory Agency has suspended the use and sale of Amgen’s rare-disease drug Tavneos to new patients after concluding that pivotal clinical trial data were unreliable. Tavneos, sold in Britain as Avacopan Vifor by CSL Vifor, is used with other medicines to treat severe autoimmune diseases that inflame small blood vessels and can damage the kidneys and lungs.

The regulator said the main trial could no longer prove the drug worked or show that its benefits outweighed its risks, and plans to revoke UK approval on March 1, 2027. Patients already taking the medicine may continue for six months while doctors assess alternatives, with the agency advising patients not to stop treatment without consulting a specialist.

Amgen disagreed with the UK decision and said regulators did not adequately weigh evidence from clinical trials and more than 20 published real-world studies. The European Commission revoked Tavneos’ approval in August, while the U.S. FDA has proposed withdrawing the drug over unproven effectiveness and false statements in the original application, also linking Tavneos to 76 cases of serious liver injury, including eight deaths.