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NEWS

What is happening in the world of Vasculitis ?

MHRA concludes UK review of avacopan

  • Peter Verhoeven
  • September 2, 2026
  • 1:08 pm

MHRA concludes UK review of avacopan

suspended now,
revocation set for March 2027

On 1 September 2026, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) concluded its review of avacopan — sold in the UK as Avacopan Vifor, previously known as Tavneos. Like the EMA in August, MHRA found that the ADVOCATE trial data can no longer be relied upon, and that the benefit-risk balance is no longer positive.

But where the EU authorisation was revoked outright, MHRA has built in a runway. From 1 September, avacopan can no longer be started in new patients. Existing UK patients, however, can keep receiving it for a defined six-month transition period, with supply guaranteed by the manufacturer — before MHRA formally revokes the UK authorisation on 1 March 2027.

Same evidence, same one medicine, two issues story we’ve been following since spring — just a different regulatory route to get there.

If you are being treated with avacopan in the UK, don’t change or stop treatment without first speaking to your specialist.

VI continues to follow avacopan/Tavneos across all regulators and will keep you updated.

Source: MHRA press release, 1 September 2026.

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