MHRA suspends Avacopan Vifor following concerns over clinical trial data integrity

1st September 2026

Summary: The MHRA has concluded that the available evidence no longer supports a positive benefit-risk balance for Avacopan Vifor, previously known as Tavneos, following concerns about the integrity and reliability of data from its pivotal clinical study. The agency determined that the study could no longer be relied upon to demonstrate the medicine's efficacy and suspended its use, supply and sale to new patients from 1st September 2026. Existing patients may continue receiving treatment during a six-month managed withdrawal period, with the MHRA intending to revoke the UK marketing authorisation on 1st March 2027. The decision highlights the critical importance of clinical data integrity in supporting regulatory approvals.

Link: https://www.gov.uk/government/news/mhra-concludes-review-of-avacopan-vifor-following-reassessment-of-benefit-risk-balance

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