MHRA concludes review of Avacopan Vifor following reassessment of benefit-risk balance
The UK’s MHRA has suspended new prescriptions of Avacopan Vifor and will revoke its licence in March 2027 after finding the pivotal trial data unreliable, requiring existing patients to switch treatments within six months.
The Medicines and Healthcare products Regulatory Agency (MHRA) has concluded its review of Avacopan Vifor, determining that the pivotal clinical study data underpinning its authorisation is no longer reliable enough to support a positive benefit-risk balance. The regulator acted after concerns were raised about the integrity of the study’s findings, prompting a reassessment of the medicine’s efficacy. The MHRA’s decision follows advice from the Commission on Human Medicines and representations from patients and healthcare professionals.
The MHRA has instructed the marketing authorisation holder to suspend the supply, sale, and use of Avacopan Vifor for new patients from 1 September 2026. Existing patients will continue to receive the medicine during a six-month managed withdrawal period, after which the UK marketing authorisation will be revoked on 1 March 2027. The marketing authorisation holder has confirmed supply will be maintained throughout this transition to ensure patient safety.
Avacopan Vifor was authorised in the UK on 6 May 2022 for treating adults with severe, active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), rare autoimmune diseases affecting small blood vessels. Healthcare professionals have been advised not to initiate treatment in new patients and to review current patients promptly to consider alternative therapies. Patients are urged not to stop taking the medicine without consulting their specialist first.
The MHRA emphasised that patient safety remains its highest priority and that the decision was based on robust, fact-based judgements. Existing risk minimisation measures, including increased monitoring of liver function and white blood cell counts, continue to apply. Suspected adverse reactions should be reported via the MHRA Yellow Card scheme. The regulator is an executive agency of the Department of Health and Social Care.