UK Suspends Sales of Rare-Disease Drug Tavneos Over Unreliable Data
The UK's medicines regulator has suspended sales of Amgen's rare-disease drug Tavneos to new patients due to unreliable data from its main trial. The Medicines and Healthcare products Regulatory Agency (MHRA) announced this decision on Tuesday, citing concerns that the study could no longer prove the drug's effectiveness or whether its benefits outweighed the risks.
Tavneos is used in combination with other medicines to treat severe autoimmune diseases that cause inflammation in small blood vessels and can damage the kidneys and lungs. While patients already receiving the drug can continue for six months, doctors are advised to consider alternatives as soon as possible. The MHRA plans to revoke UK approval for Tavneos on March 1, 2027.
Amgen acquired ChemoCentryx, the developer of Tavneos, for $3.7 billion in 2022. Amgen holds the US rights to the drug, while CSL Vifor holds commercial rights outside the US, including in Britain. An Amgen spokesperson expressed disagreement with the MHRA's decision, stating that the regulator did not adequately consider evidence from clinical trials and published real-world studies.