UK Regulator Suspends Rare-Disease Drug Tavneos Over Unreliable Trial 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 a main trial. The regulator stated that this means the study can no longer demonstrate the drug's effectiveness or prove its benefits outweigh the risks.
The MHRA plans to revoke UK approval for Tavneos on March 1, 2027. However, patients currently taking the medication can continue treatment for six months while doctors find alternative options. The regulator advises these patients not to stop their treatment without consulting a specialist.
Amgen acquired ChemoCentryx, which developed Tavneos, for $3.7 billion in 2022 and holds U.S. rights to the drug. CSL Vifor markets the medication in Britain. Amgen claims that the regulator did not adequately consider evidence from clinical trials and over 20 published real-world studies supporting the drug.