MHRA concludes review of Avacopan Vifor following reassessment of benefit-risk balance
Avacopan Vifor is used in the treatment of some rare autoimmune diseases affecting small blood vessels.
The Medicines and Healthcare products Regulatory Agency (MHRA) has completed its 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.
This review was prompted by information that raised questions about the integrity and reliability of data from the pivotal clinical study underpinning the medicine’s authorisation. Following a detailed assessment of all available evidence and advice from the Commission on Human Medicines (CHM), and representations made by patients and healthcare professionals, the MHRA concluded that the study can no longer be relied upon to demonstrate the efficacy of Avacopan Vifor.
The MHRA has therefore informed the marketing authorisation holder of its decision to suspend the use, supply, and sale of Avacopan Vifor to new patients from 1 September 2026.
To allow patients currently receiving the medicine to be safely transitioned to alternative treatment options, supply will be permitted only to existing patients during a six-month managed withdrawal period, after which the MHRA intends to revoke the UK marketing authorisation on 1 March 2027. The marketing authorisation holder has guaranteed supply to cover this period.
The action has been taken under Regulations 69 and 71 of the Human Medicines Regulations 2012, which provide for the suspension of the use, supply, and sale of a medicinal product.
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.
Julian Beach, MHRA Executive Director Healthcare Quality and Access, said:
“Patient safety is our highest priority. Following a thorough review of the available evidence, we have concluded that the data supporting the efficacy of Avacopan Vifor is no longer sufficiently reliable to support a positive benefit-risk balance.
“We have therefore taken regulatory action to suspend the use, supply, and sale of this medicine to new patients. We intend to subsequently revoke the medicine’s UK marketing authorisation following a transitional period.”
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.
Patients taking Avacopan Vifor should not stop treatment without first discussing their care with their specialist healthcare professional. Existing risk minimisation advice in the product information continues to apply. This includes monitoring liver function, for which the recommended testing frequency was recently increased, as well as monitoring white blood cell count and assessing patients for any serious infections.
Any suspected adverse reactions should be reported via the MHRA Yellow Card scheme.
Notes to editors:
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Avacopan Vifor (previously known as Tavneos), in combination with a rituximab or cyclophosphamide regimen, was authorised in the UK on 6 May 2022 for the treatment of adult patients with severe, active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA).
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The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
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The MHRA is an executive agency of the Department of Health and Social Care.
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The Commission on Human Medicines (CHM) is the government’s independent expert scientific advisory body.
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For media enquiries, please contact the newscentre@mhra.gov.uk, or call on 020 3080 7651.