Following review, the MHRA has concluded that the available evidence no longer supports a positive benefit-risk balance for Avacopan Vifor (previously known as Tavneos), used in combination with rituximab or cyclophosphamide for adults with severe, active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA).
The decision follows concerns about the integrity and reliability of data from the pivotal clinical study supporting the medicine’s authorisation. Following a detailed review, including advice from the Commission on Human Medicines and input from patients and healthcare professionals, the MHRA determined that the study can no longer reliably demonstrate the medicine’s efficacy.
Use, supply and sale of Avacopan Vifor to new patients has been suspended from 1 September 2026. Existing patients will continue to have access during a six-month managed withdrawal period, allowing safe drug withdrawal. The MHRA intends to revoke the UK marketing authorisation on 1 March 2027.
Healthcare professionals should not initiate treatment with Avacopan Vifor in new patients and should review patients currently receiving the medicine at the earliest opportunity, considering appropriate alternative treatment options where necessary.
Read the full press release.
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