InflaRx weighs broader EU strategy for vasculitis drugs after Tavneos setback

InflaRx N.V. said on June 30, 2026 that it is assessing the feasibility of broadening its development and registrational strategy for AAV in Europe.¹ The move follows action by the EMA's Committee for Medicinal Products for Human Use, which recommended revoking the marketing authorization for Tavneos in the European Union, a decision announced on June 26, 2026.¹

The company said it plans to engage with EMA regarding both its anti-C5a antibody vilobelimab, approved under exceptional circumstances as GOHIBIC in Europe for SARS-CoV-2-induced acute respiratory distress syndrome, and its next-generation oral C5aR inhibitor izicopan.¹ InflaRx framed this as part of an effort to determine the most efficient development pathway to bring the C5a/C5aR inhibition mechanism to patients.¹

Separately, InflaRx said its existing izicopan Phase 2 planning in AAV is moving forward without disruption in multiple regions, unaffected by the Tavneos development.

On the biologic side, InflaRx considers vilobelimab to be a Phase 3-ready asset in AAV, having completed two Phase 2 studies in the U.S. and Europe.¹ A related antibody, marketed under the title "BDB-001," is also in play: it uses the same cell line as vilobelimab, has finished Phase 2 testing, and is now being advanced by InflaRx's China partner, Staidson BioPharmaceuticals Co., Ltd., which initiated a Phase 3 trial in China in 2025 that remains ongoing.¹

InflaRx CEO Niels C. Riedemann said recent developments in the ANCA-associated vasculitis treatment landscape reinforce the seriousness of the disease and the importance of therapies with a strong mechanistic rationale, and that the company has built a differentiated portfolio around the C5a/C5aR pathway through vilobelimab and izicopan.¹