EMA Tightens Liver Safety Checks for Tavneos After Fatal Cases
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EMA's PRAC has tightened monitoring and stopping rules for Tavneos (avacopan) after reviewing serious liver injury cases, including fatal outcomes. The update adds liver injury as a rare side effect and creates a new regulatory watchpoint for Amgen and ANCA-associated vasculitis teams.
Avacopan liver injury pushed EMA’s Pharmacovigilance Risk Assessment Committee to tighten Tavneos monitoring in June 2026. After reports of drug-induced liver injury and vanishing bile duct syndrome—including fatal cases—PRAC backed stricter liver tests, clearer stop rules, and a DHPC for GPA and MPA clinicians.
Contents10 sections
Key Takeaways
- PRAC (8–11 June 2026) endorsed reinforced LFT monitoring and stopping rules for Tavneos (avacopan) to mitigate DILI and VBDS risk.
- Baseline hepatic transaminases and total bilirubin are required before starting therapy.
- Monitor LFTs at least every two weeks for three months, then every four weeks for three months, then as clinically indicated.
- On 26 June 2026, CHMP recommended EU marketing revocation for Tavneos pending a European Commission decision; no new starts, switch existing patients.
What did PRAC decide on avacopan liver injury?
PRAC’s 8–11 June 2026 highlights say the committee endorsed a DHPC on reinforced liver monitoring and stopping rules for Tavneos. The update followed further characterisation of DILI and VBDS after serious liver injury reports, including fatal outcomes.
Tavneos treats adults with severe, active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA). Primary text is in the EMA PRAC meeting highlights for 8–11 June 2026.
What are the reinforced liver monitoring rules?
Before starting Tavneos, clinicians must run liver function tests, including hepatic transaminases and total bilirubin. During therapy, LFTs must be checked at least every two weeks for the first three months, then every four weeks for the next three months, then as clinically indicated.
- Stop if liver-source ALP is over twice the upper limit of normal
- Stop if clinical VBDS symptoms appear, such as jaundice or itching
- If VBDS is suspected, stop immediately and permanently
- These rules add to stopping criteria already in the product information
How does CHMP’s June 26 review change the story?
On 26 June 2026, CHMP recommended revoking the EU marketing authorisation for Tavneos. The referral found Advocate study data could not be relied on after GCP breaches and incorrect, misleading data handling. Without reliable efficacy evidence, benefits were no longer proven to outweigh risks.
CHMP said no new patients should start Tavneos and existing patients should switch to alternatives. Liver monitoring continues until treatment stops. See the EMA news item recommending Tavneos revocation (26 June 2026).
What liver risks did EMA restate?
EMA links Tavneos to higher risk of DILI and VBDS, including fatal cases. Most events cluster in the first three months. For patients stopping after less than three months of use, monitor LFTs at least every two weeks until three months from start. For longer exposure, monitor every four weeks up to six months, then as needed.
Referral status and procedure detail sit on the EMA Tavneos Article 20 referral page.
What this means for Amgen and ANCA teams
For EU markets, the near-term operational message is stop new starts and plan switches if the Commission confirms revocation. Pharmacovigilance teams should treat avacopan liver injury as an active, fatal-outcome signal, not a label footnote.
BD and medical affairs should separate the June PRAC monitoring DHPC from the later CHMP efficacy-data finding. Both now sit in the same EU risk story.
What remains unproven or pending
A European Commission decision is still required before revocation is legally binding across Member States. Cross-regional label outcomes can diverge. Case counts and causality fractions outside EMA’s published summaries are not restated here without a primary table.
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Frequently Asked Questions
What did PRAC decide on avacopan liver injury monitoring?
At its 8–11 June 2026 meeting, PRAC endorsed reinforced liver tests and stopping rules for Tavneos (avacopan), plus a direct healthcare professional communication, after further characterisation of DILI and vanishing bile duct syndrome, including fatal cases.
How often should liver tests be done on Tavneos?
Baseline hepatic transaminases and total bilirubin are required before starting. During treatment, monitor at least every two weeks for the first three months, then every four weeks for the next three months, then as clinically indicated.
Did EMA go beyond monitoring for Tavneos?
Yes. On 26 June 2026, CHMP recommended revoking the EU marketing authorisation for Tavneos because benefits were no longer proven to outweigh risks after Advocate study data integrity and GCP concerns, while liver risks including fatal DILI and VBDS remain.
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