UK Suspends Rare-Disease Drug Tavneos Over Unreliable Data

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has suspended the use of Amgen's rare-disease drug Tavneos for new patients due to unreliable data from its main trial. The MHRA stated that the study could no longer prove the drug's effectiveness or that its benefits outweighed the risks.

Tavneos, sold as Avacopan Vifor in Britain by CSL Vifor, is used with other medicines to treat severe autoimmune diseases that cause inflammation in small blood vessels and can damage the kidneys and lungs. Patients already receiving the drug can continue for six months while doctors consider alternatives.

The MHRA plans to revoke UK approval for Tavneos on March 1, 2027. This decision follows a similar move by the European Commission, which revoked Tavneos' approval in August after finding key trial data to be unreliable.

Amgen has acquired ChemoCentryx, the developer of Tavneos, for $3.7 billion in 2022. Amgen holds the U.S. rights, while CSL Vifor holds commercial rights in selected markets outside the U.S., including Britain.