UK Suspends Sales of Rare-Disease Drug Tavneos Over Unreliable Data

Britain's medicines regulator has suspended the sale of rare-disease drug Tavneos to new patients due to unreliable data from its main study. The Medicines and Healthcare products Regulatory Agency (MHRA) said that this means the study cannot prove the drug works or that its benefits outweigh the risks.

Tavneos, sold as Avacopan Vifor in Britain by CSL Vifor, is used with other medicines to treat severe autoimmune diseases. The MHRA plans to revoke UK approval for the drug on March 1, 2027.

Patients already receiving Tavneos can continue treatment for six months while doctors consider alternatives. The regulator has advised patients not to stop taking the medication without consulting a specialist.

The decision comes after the European Commission revoked Tavneos' approval in August and the US FDA proposed withdrawing the drug due to unproven effectiveness and false statements in its original application.

Amgen, which developed the drug through ChemoCentryx, acquired for $3.7 billion in 2022, disagrees with the MHRA's decision. The company says that regulators did not adequately consider evidence from clinical trials and real-world studies supporting the drug.