Avacopan update 24/07/26

Vifor, which markets avacopan in the UK, has issued a safety communication, in agreement with the MHRA, advising that no new patients should be started on the medicine while the MHRA review is ongoing.

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.
6. The marketing sponsor Vifor recommends that NO NEW patients should be started while the MHRA investigation is ongoing

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

8 July Update

8 May Update