EMA strengthens liver monitoring requirements for Tavneos (avacopan)
The safety committee of the European Medicines Agency (EMA), the PRAC, adopted new requirements for the use of Tavneos (avacopan) on 12 June 2026. Healthcare professionals will receive a direct communication from the marketing authorisation holder outlining the updated recommendations.
What has been decided?
The PRAC has recommended strengthening liver monitoring during treatment with Tavneos and introducing new stopping rules. The trigger for these measures is a series of recent reports of serious liver injury in patients using Tavneos, including cases with a fatal outcome. One of the conditions the new rules specifically address is vanishing bile duct syndrome (VBDS) — a rare condition in which the small bile ducts inside the liver are progressively damaged and disappear over time.
What changes in practice?
Liver function tests must be performed before starting treatment. During treatment, the following monitoring schedule now applies:
- First three months: at least every two weeks
- Months four to six: every four weeks
- Thereafter: as clinically indicated
Treatment must be stopped immediately if certain liver values are too high, or if signs of jaundice or severe itching develop. If VBDS is suspected, treatment must be permanently discontinued.
EMA review still ongoing
This PRAC decision is separate from the ongoing Article 20 review that the EMA initiated earlier, following questions about the reliability of data from the ADVOCATE trial. That broader review has not yet concluded. Tavneos remains available in Europe.
Following our earlier publications on this subject, Vasculitis International continues to monitor both the EMA review and developments at the US FDA closely.
What does this mean for patient organisations?
We encourage VPAGs and other vasculitis patient organisations to inform their members about these new requirements and to urge them to discuss the updated liver monitoring schedule with their treating specialist. The key message for patients is straightforward: do not stop treatment without consulting your doctor, but raise the new monitoring requirements at your next appointment.
We will continue to keep you informed as further developments unfold.
Source: EMA PRAC Meeting Highlights, 8–11 June 2026