UK Regulator Suspends Rare-Disease Drug Tavneos Over Unreliable Data

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has suspended Amgen's rare-disease drug Tavneos for new patients due to unreliable data from its main trial. The suspension was made effective immediately, with existing patients allowed to continue treatment for six months while doctors consider alternative options.

Tavneos, also known as Avacopan Vifor in Britain and sold by CSL Vifor, is used to treat severe autoimmune diseases that cause inflammation in small blood vessels and can damage the kidneys and lungs. The drug was developed by ChemoCentryx, which Amgen acquired for $3.7 billion in 2022.

Amgen disputes the MHRA's decision, stating that the regulator did not adequately consider evidence from clinical trials and over 20 published real-world studies supporting the drug. The European Commission revoked Tavneos' approval in August after finding key trial data to be unreliable, while the US FDA has proposed withdrawing the drug due to unproven effectiveness and false statements in its original application.