UK regulator suspends new patients from receiving Tavneos (Avacopan Vifor) amid data concerns

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has decided to stop prescribing Tavneos, known locally as Avacopan Vifor, to any new patients.

The decision follows the regulator’s review of all available evidence and concerns raised by patients and clinicians about the reliability of data from the pivotal trial that supported the drug’s authorization for ANCA‑associated vasculitis.

CSL Vifor retains the marketing authorization in the UK, while Amgen continues to sell the drug in the United States, where it received FDA approval in 2021 after Amgen’s 2022 acquisition of ChemoCentryx.

Amgen expressed disappointment and disagrees with the MHRA’s move, and the company is awaiting an upcoming FDA hearing to address the raised issues.