UK Suspends Tavneos Over Unreliable Clinical Trial Data
The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK has suspended the use of Amgen's rare-disease drug Tavneos for new patients, citing unreliable data from the main trial. The regulator plans to revoke UK approval for the drug on March 1, 2027.
Tavneos is used to treat severe autoimmune diseases that cause inflammation in small blood vessels and can damage the kidneys and lungs. It was developed by ChemoCentryx, which Amgen acquired for $3.7 billion in 2022.
The MHRA said unreliable data from the main trial meant it could no longer prove the drug worked or that its benefits outweighed the risks. Patients already receiving the drug can continue treatment for six months while doctors consider alternatives.