UK Suspends Amgen's Tavneos Over Unreliable Trial Data
The UK's medicines regulator has suspended the use of Amgen's Tavneos for new patients due to unreliable data from its main trial. This means that only those already receiving the drug can continue treatment for six months while doctors consider alternative options.
Tavneos, also known as Avacopan Vifor in Britain by CSL Vifor, is used with other medications to treat severe autoimmune diseases. The regulator has said it can no longer prove that Tavneos works or that its benefits outweigh the risks.
The suspension follows a similar decision by the European Commission in August, which revoked Tavneos' approval after finding key trial data unreliable. In the US, the FDA has also proposed withdrawing the drug, citing unproven effectiveness and false statements in the original application.