Update on avacopan following regulatory developments

National clinical leaders for renal and rheumatology services have published an agreed interim position on the use of Tavneos® (avacopan) while the Medicines and Healthcare products Regulatory Agency (MHRA) completes its review. This letter has been issued to Renal Services and Rheumatology Clinical Reference Groups and Renal Clinical Networks to support a consistent approach across England.

Read the letter

The interim position follows recent regulatory developments relating to avacopan, including the European Medicines Agency (EMA) recommendation to revoke the medicine’s European marketing authorisation following concerns about the integrity and reliability of data from the pivotal clinical trial supporting its licence. The letter also notes that the US Food and Drug Administration (FDA) has separately proposed withdrawing the medicine in the United States. Regulatory decisions made by the EMA and FDA do not apply in the UK.

While the MHRA review is ongoing, avacopan remains licensed and available for use in the UK.

Interim guidance pending the MHRA review 

Services and clinicians are asked to adopt the following position while the MHRA review is completed:

1. The MHRA advises that these issues remain under review. Until this concludes, avacopan remains licensed and available in the UK, with existing risk-minimisation measures unchanged.
2. Treatment decisions should continue to be made by expert vasculitis clinicians within specialist MDTs, based on individual patient benefit–risk assessment. For post-pubescent children, use of the drug should continue to be discussed in line with the criteria outlined in the ‘Commissioning medicines for children in specialised services’ policy. The current regulatory position should be discussed with both existing and prospective patients as part of shared decision-making.
3. Patients on avacopan should continue liver function monitoring, along with white blood cell monitoring and assessment for serious infection, in line with product information.
4. To ensure consistency, services should follow this national position and manage any treatment changes through the standard specialist MDT process.
5. Suspected adverse reactions should be reported via the MHRA Yellow Card scheme.

Further guidance will be issued once the MHRA review has concluded.

Related information

• NHS England interim national position
• MHRA review of avacopan (June 2026)
• UKIVAS statement on avacopan (May 2026)
• Patient information from Vasculitis International
• Patient information from Vasculitis UK