The Medicines and Healthcare products Regulatory Agency (MHRA) has announced the suspension of Avacopan Vifor for new patients, effective from 1 September 2026. This decision follows a review that questioned the integrity and reliability of data from the pivotal clinical study supporting the medicine's authorisation.
The MHRA concluded that the study can no longer be relied upon to demonstrate the efficacy of Avacopan Vifor. Julian Beach, MHRA Executive Director Healthcare Quality and Access, stated that patient safety is the highest priority and the data supporting efficacy is no longer sufficiently reliable.
Patients currently receiving Avacopan Vifor will be permitted supply for a six-month managed withdrawal period to allow for a safe transition to alternative treatments. The MHRA intends to revoke the UK marketing authorisation for the medicine on 1 March 2027.
Avacopan Vifor is used in combination with other regimens for adults with severe, active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), which are rare autoimmune diseases affecting small blood vessels.