Amgen's Rare-Disease Drug Tavneos Suspended in UK Due to Unreliable Data
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has suspended the use and sale of Amgen's rare-disease drug Tavneos to new patients. This decision was made due to unreliable data from the main trial that supported the drug's approval.
Tavneos, also known as Avacopan Vifor, is prescribed alongside other medicines to treat severe autoimmune diseases that cause inflammation in small blood vessels and can damage the kidneys and lungs. The regulator plans to revoke UK approval for the drug on March 1, 2027.
Amgen acquired ChemoCentryx, which developed Tavneos, for $3.7 billion in 2022. Amgen holds U.S. rights to the drug, while CSL Vifor holds commercial rights in selected markets outside the U.S., including Britain. An Amgen spokesperson stated that the company disagrees with the MHRA's decision and is concerned about its impact on rare-disease patients.