Business UpdateJun 30, 2026, 04:08 PM
InflaRx to Broaden AAV Strategy in Europe After EMA Tavneos Ruling
AI Summary
InflaRx N.V. announced it is assessing the feasibility of broadening its development and registrational strategy for ANCA-Associated Vasculitis (AAV) in Europe. This decision comes after the European Medicines Agency (EMA) recommended revoking the marketing authorization for Tavneos, a competitor drug, on June 26, 2026. InflaRx plans to engage with the EMA regarding its anti-C5a antibody vilobelimab and its oral C5aR inhibitor izicopan, aiming to determine the most efficient development pathway for these therapies in AAV. The company views vilobelimab as a Phase 3-ready asset for AAV, and izicopan's Phase 2 planning for AAV is ongoing.
Key Highlights
- InflaRx is assessing a broadened development and registrational strategy for AAV in Europe.
- This assessment follows EMA's recommendation to revoke marketing authorization for Tavneos.
- The company intends to engage EMA regarding vilobelimab and izicopan for AAV.
- Vilobelimab is considered Phase 3-ready for AAV, having completed two Phase 2 studies.
- Phase 2 planning for izicopan in AAV continues uninterrupted across multiple geographies.
- Collaborator Staidson is conducting a Phase 3 trial for BDB-001 (vilobelimab cell line) in AAV in China.
- Vilobelimab and izicopan provide a complementary biologic and oral pipeline for AAV.
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