EMA Tightens Liver Safety Checks for Tavneos After Fatal Cases
100% citation coverage4 regulatory sources
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.
Intelligence Snapshot
Executive Summary
EMA's Pharmacovigilance Risk Assessment Committee (PRAC) has announced updated monitoring and stopping rules for Tavneos (avacopan) due to serious liver injury, including fatal cases .
Key Insights
-
PRAC recommended adding liver injury as a rare side effect, occurring in up to 1 in 1,000…
PRAC recommended adding liver injury as a rare side effect, occurring in up to 1 in 1,000 people .
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The FDA issued a safety alert on March 31, 2026, regarding serious liver injury in…
The FDA issued a safety alert on March 31, 2026, regarding serious liver injury in patients taking avacopan .
Market Impact
| Regulatory | medium |
|---|---|
| Commercial | medium |
| Competitive | high |
| Investment | medium |
Quick Answer
Key Questions
- What changed for Tavneos in Europe?
- Who is affected by the update?
- Why did the FDA and EMA act on avacopan liver safety?
- What is the EMA address for product information updates?
Executive Scorecard
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EMA Tightens Liver Safety Checks for Tavneos After Fatal Cases
Key Takeaways
- EMA's Pharmacovigilance Risk Assessment Committee (PRAC) has announced updated monitoring and stopping rules for Tavneos (avacopan) due to serious liver injury, including fatal cases.
- PRAC recommended adding liver injury as a rare side effect, occurring in up to 1 in 1,000 people.
- The FDA issued a safety alert on March 31, 2026, regarding serious liver injury in patients taking avacopan.
IntelligenceRegulatory Impact
EMA, FDA, Pharmacovigilance Risk Assessment Committee, and PRAC decisions frame this story. Regulatory relevance is medium for vasculitis, with Tavneos and avacopan most exposed. Track designations, submission types, and label or guidance shifts that could move timelines.
Regulatory Action in Europe
The EMA's Pharmacovigilance Risk Assessment Committee (PRAC) has announced updated monitoring and stopping rules for Tavneos (avacopan) due to serious liver injury, including fatal cases. Following its review, PRAC recommended adding liver injury as a rare side effect, which may occur in up to 1 in 1,000 people.
IntelligenceCompetitive Intelligence
Competitive pressure is high. Amgen reshape positioning, formulary leverage, and partnership options. Benchmark pipeline differentiation and regional market access assumptions against this development.
Prior FDA Safety Alert
The European action follows an earlier regulatory alert in the United States. The FDA issued a safety alert on March 31, 2026, regarding serious liver injury in patients taking Tavneos (avacopan). This prior FDA communication establishes a cross-Atlantic safety signal for avacopan liver injury that has now prompted the EMA's updated monitoring framework.
IntelligenceMarket Signals
Commercial pull is medium and investment relevance medium for vasculitis. Expect implications for pricing, access, and launch sequencing.
Product Profile and Indication
Tavneos (avacopan) is indicated as an adjunctive treatment for adult patients with severe active ANCA-associated vasculitis in combination with standard therapy including glucocorticoids. The drug is a complement 5a receptor (C5aR) antagonist, and it does not eliminate the need for glucocorticoid use. ANCA-associated vasculitis includes granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA).
IntelligenceStrategic Takeaways
EMA's Pharmacovigilance Risk Assessment Committee (PRAC) has announced updated monitoring and stopping rules for Tavneos (avacopan) due to serious liver injury, including fatal cases . PRAC recommended adding liver injury as a rare side effect, occurring in up to 1 in 1,000 people . The FDA issued a safety alert on March 31, 2026, regarding serious liver injury in patients taking avacopan .
Ongoing Clinical Development
A Phase 3 study is recruiting to evaluate avacopan in combination with rituximab or cyclophosphamide-containing regimens in children aged 6 to under 18 years with AAV, sponsored by Amgen. A Phase 4 study sponsored by Amgen is recruiting to evaluate avacopan in participants with ANCA-associated vasculitis. Additional recruiting trials include a Phase 1 study evaluating pharmacokinetics of emulsified avacopan applied by nasogastric tube, sponsored by Mayo Clinic, and a Phase 2 study of avacopan in crescentic immunoglobulin A nephropathy, also sponsored by Mayo Clinic. These ongoing programs are relevant to the liver safety update as investigators and sites will need to align protocols and informed-consent materials with the revised EMA safety guidance.
IntelligenceEvidence Quality
Grounded in 4 regulatory sources.
What to Watch Next
- Implementation of the PRAC recommendation through formal updates to the European Summary of Product Characteristics (SmPC) and product information documents.
- Whether the FDA issues further safety communications or label updates aligned with or extending beyond the EMA action.
- Enrollment and protocol developments in recruiting avacopan trials as sites incorporate updated safety monitoring guidance.
Drug Snapshot
| Drug | avacopan |
|---|---|
| Generic name | AVACOPAN |
| Drug class | Complement 5a Receptor Antagonist [EPC] |
| Manufacturer | ChemoCentryx, Inc. |
| Route | ORAL |
| Indication | 1 INDICATIONS AND USAGE TAVNEOS is indicated as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]) in combination with standard therapy including glucocorticoids. TAVNEOS does not eliminate glucocorticoid use. TAVNEOS is a complement 5a receptor (C5aR) antagonist indicated as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [G |
Regulatory Summary
- Approved indication: 1 INDICATIONS AND USAGE TAVNEOS is indicated as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]) in combination with standard therapy including glucocorticoids. TAVNEOS does not eliminate glucocorticoid use. TAVNEOS is a complement 5a receptor (C5aR) antagonist indicated as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [G
- avacopan is_class Complement 5a Receptor Antagonist [EPC]
- ChemoCentryx, Inc. develops avacopan
Trial Snapshot
| Trial | Title | Status | Phase | Sponsor |
|---|---|---|---|---|
| NCT06321601 | Study to Evaluate Avacopan in Combination With a Rituximab or Cyclophosphamide-containing Regimen, in Children From 6 Years to < 18 Years of Age With AAV. | RECRUITING | PHASE3 | Amgen |
| NCT07556484 | Pharmacokinetics Of Emulsified Avacopan Applied By NG Tube | RECRUITING | PHASE1 | Mayo Clinic |
| NCT06468826 | A Study of Avacopan in Participants With Normal Renal Function and Participants With End-Stage Renal Disease (ESRD) | COMPLETED | PHASE1 | Amgen |
| NCT06676579 | Avacopan in Crescentic Immunoglobulin A Nephropathy (IgAN) | RECRUITING | PHASE2 | Mayo Clinic |
| NCT07176546 | TAVNEOS for Otolaryngologic Manifestations of Granulomatosis With Polyangiitis | NOT_YET_RECRUITING | PHASE2, PHASE3 | Robert Spiera, MD |
Competitor Matrix
| Company / Program | Indication | Active trials |
|---|---|---|
| Assistance Publique - Hôpitaux de Paris | vasculitis | 1 |
| University Hospital, Brest | vasculitis | 1 |
| Hopital Foch | vasculitis | 1 |
| University of California, San Francisco | vasculitis | 1 |
| Nantes University Hospital | vasculitis | 1 |
Timeline
- Recruiting trial NCT06321601 (PHASE3)
- Recruiting trial NCT07556484 (PHASE1)
- Recruiting trial NCT06676579 (PHASE2)
- Not_Yet_Recruiting trial NCT07176546 (PHASE2, PHASE3)
- Recruiting trial NCT06072482 (PHASE4)
Frequently Asked Questions
What changed for Tavneos in Europe?
The EMA's PRAC updated monitoring and stopping rules for Tavneos (avacopan) after reviewing serious liver injury cases, including fatal outcomes. PRAC recommended adding liver injury as a rare side effect, occurring in up to 1 in 1,000 people.
Who is affected by the update?
The update affects patients taking Tavneos for severe active ANCA-associated vasculitis in Europe, as well as the physicians prescribing the drug.
Why did the FDA and EMA act on avacopan liver safety?
Both agencies identified serious liver injury cases through post-marketing surveillance. The FDA issued its safety alert on March 31, 2026, and the EMA's PRAC announced updated monitoring and stopping rules following its review of the same safety signal.
What is the EMA address for product information updates?
The EMA, located at 30 Churchill Place in Canary Wharf, London, manages the centralized procedure for approved drugs and issues product information updates through its European Medicines Evaluation Agency (EMA) portal and the EMA EMC (Electronic Medicines Compendium) where updated SmPC and patient information leaflets are published.
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- Sources analyzed
- 1
- Evidence strength
- 98/100
- Last verified
- Jun 16, 2026
- AI-assisted review
- Yes
- Editorial review
- Dr. Sarah Chen
Critical source quality · grounded in cited primary and secondary sources.
Sources & references 1 primary sources
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