08 September 2026
The Medicines and Healthcare products Regulatory Agency (MHRA) has concluded a review of Avacopan Vifor, previously known as Tavneos, and determined that the available evidence no longer supports a positive benefit-risk balance for the medicine.
From 1 September 2026, the use, supply and sale of Avacopan Vifor has been suspended for new patients in the UK. The MHRA review followed concerns about the integrity and reliability of data from the pivotal clinical trial supporting the medicine’s authorisation, ADVOCATE.
Patients currently receiving Avacopan Vifor will continue to have access to the medicine during a six-month managed withdrawal period, allowing healthcare professionals to review their treatment and consider appropriate alternatives. The MHRA intends to revoke the UK marketing authorisation on 1 March 2027.
Healthcare professionals should not initiate Avacopan Vifor for new patients. Patients currently taking the medicine should not stop treatment without first discussing their care with their specialist healthcare professional.