UK regulator suspends Amgen rare-disease drug Tavneos for new patients
Britain's Medicines and Healthcare products Regulatory Agency (MHRA) has suspended the use and sale of Amgen's rare-disease drug Tavneos (Avacopan Vifor) to new patients. The regulator cited unreliable data from the main study that supported the drug's approval as the reason for its suspension. CSL Vifor markets and sells Tavneos in the UK, while Amgen holds U.S. rights to the drug.
The MHRA will revoke the drug's UK approval on March 1, 2027. Patients currently taking Tavneos can continue their treatment for six months while doctors explore alternative options. The regulator advised patients not to discontinue treatment without consulting a specialist. Amgen, the drug's developer, expressed disagreement with the MHRA's decision and stated that the regulator did not consider sufficient evidence from clinical trials and real-world studies supporting the drug's benefits.
The European Commission had already revoked Tavneos' approval in August due to concerns over unreliable trial data.
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