RegulatoryJun 30, 2026, 07:32 AM
InflaRx to Engage EMA on AAV Approval Path for Vilobelimab & Izicopan
AI Summary
InflaRx N.V. announced its intention to engage with the European Medicines Agency (EMA) to evaluate the regulatory path to approval for its anti-C5a antibody vilobelimab and oral C5aR inhibitor izicopan in ANCA-associated vasculitis (AAV). This strategic move follows the EMA's recommendation to revoke the marketing authorization for a competitor drug, Tavneos, in the EU. The company views vilobelimab as a Phase 3-ready asset for AAV, while Phase 2 planning for izicopan in AAV continues as planned.
Key Highlights
- InflaRx intends to engage with the EMA regarding the regulatory path to approval for vilobelimab and izicopan in ANCA-associated vasculitis (AAV).
- This assessment follows the EMA's CHMP recommendation to revoke the marketing authorization for competitor Tavneos in the European Union.
- Vilobelimab is considered a Phase 3-ready asset in AAV, having completed two Phase 2 studies in the U.S. and Europe.
- InflaRx's collaborator, Staidson BioPharmaceuticals, is evaluating BDB-001 (vilobelimab cell line) in a Phase 3 trial in AAV in China.
- Previously announced Phase 2 planning with izicopan in AAV continues uninterrupted across multiple geographies.
- Vilobelimab (GOHIBIC) is approved under exceptional circumstances in Europe for SARS-CoV-2-induced acute respiratory distress syndrome.
- Vilobelimab (GOHIBIC) has an Emergency Use Authorization from the FDA for COVID-19 in hospitalized adults in the U.S.
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