The Medicines and Healthcare products Regulatory Agency (MHRA) has suspended the use, supply, and sale of Avacopan Vifor (previously known as Tavneos) to new patients from 1 September.
The regulator completed the review of Avacopan Vifor, given to patients suffering from autoimmune diseases, and found that the medicine provided no positive benefit-risk balance, and informed the marketing authorisation holder of its decision.
This review was prompted after questions were raised about the integrity and reliability of data from a clinical study.
Supply will continue for existing patients during a six-month managed withdrawal period, and after that the MHRA intends to revoke the UK marketing authorisation on 1 March 2027.
In the UK, Avacopan Vifor, in combination with a rituximab or cyclophosphamide regimen, has been indicated for the treatment of adults with severe, active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), which are rare autoimmune diseases affecting small blood vessels.
Healthcare professionals should not initiate treatment with Avacopan Vifor in new patients and review patients currently receiving the medicine at the earliest opportunity, and consider appropriate alternative treatment options where necessary.
