UK Regulator Suspends Amgen's 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 in its main study. The regulator claims that this unreliable data makes it impossible to determine the drug's effectiveness or weigh its benefits against risks.

Tavneos, also known as Avacopan Vifor, is prescribed alongside other medications to treat severe autoimmune diseases causing inflammation in small blood vessels and damage to kidneys and lungs. CSL Vifor markets the drug in Britain.

Patients currently taking Tavneos can continue treatment for six months while doctors assess alternative options. The MHRA advises patients not to stop treatment without consulting a specialist. Amgen acquired ChemoCentryx, which developed Tavneos, for $3.7 billion in 2022.

An Amgen spokesperson expressed disagreement with the MHRA's decision and concern about its impact on rare-disease patients. The company claims that the regulator did not adequately consider evidence from clinical trials and over 20 published real-world studies supporting the drug.