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News
Britain's medicines regulator has suspended Amgen's rare-disease drug Tavneos (avacopan) for new patients, citing unreliable data from its pivotal trial. The EU already revoked its approval in August, and the U.S. FDA has proposed withdrawal too, flagging unproven effectiveness and 76 cases of serious liver injury. Existing patients can continue for up to six months while alternatives are explored.
Britain's Medicines and Healthcare products Regulatory Agency (MHRA) has suspended the use and sale of Tavneos (avacopan) to new patients, ruling that the key clinical trial underpinning its approval can no longer be considered reliable. The drug, marketed in the UK as Avacopan Vifor by CSL Vifor, is used alongside other therapies to treat severe autoimmune vasculitis — conditions that inflame small blood vessels and can seriously damage the kidneys and lungs. The UK approval is set to be formally revoked on March 1, 2027.
The move follows a cascade of regulatory actions across major markets. The European Commission revoked Tavneos' approval in August after similar concerns, and the U.S. FDA has proposed withdrawal, citing unproven effectiveness and false statements in the original application. Amgen, which acquired Tavneos developer ChemoCentryx for $3.7 billion in 2022, is contesting the U.S. withdrawal and has submitted over 70 supporting studies.
By the Numbers:
Why it matters: Tavneos was a rare approved option for a serious autoimmune condition with limited treatments. Its simultaneous regulatory unraveling across the UK, EU, and U.S. raises urgent questions about data integrity in drug approvals and leaves patients and clinicians scrambling for alternatives.
