Omeros Corporation Submits Narsoplimab Marketing Authorization Application to the European Medicines Agency for the Treatment of Ta-TMA

Published: 2025-06-27 16:56:16 ET OMER

Published on 06/27/2025 at 16:56

Omeros Corporation announced the recent submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA). The MAA includes response-based analyses in narsoplimab-treated TA-TMA patients as well as analyses comparing overall survival between narsoplimab- treated patients and a well-matched external control group. This opinion is typically adopted by the European Commission, with a final decision expected in mid-2026.

The MAA submission follows the acceptance for review by the U.S. Food and Drug Administration (FDA) of the resubmission of the Biologics License Application (BLA) for narsoplimib for the treatment of TA-TMA. The resubmission was assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 25, 2025. Importantly, inhibition of MASP-2 has been demonstrated to leave intact the antibody-dependent classical complement activation pathway, which is a critical component of the acquired immune response to infection.

A biologics license application (BLA) for use of narsoplimab in the treatment of hematopOietic stem cell transplant- associated thrombotic microangopathy (TA-TMA) is under review by the U.S., Food and Drug Administration (F FDA) and Omeros has submitted the corresponding European MAA. FDA has granted narsoplimab breakthrough therapy and orphan drug designations for TA-TMA and orphan drug status for the prevention (inhibition) of complement-mediated thrombotic microangipathy. Omeros' lead MASP-2 inhibitor narsoplimab targets the lectin pathway of complement and is the subject of a biologics license application under review by FDA for the treatment of hematOPoietic stem cell transplant -associated thrombotic microANGiopathy.

Omeros' long-acting MASP-2 inhibitor OMS1029 has successfully completed Phase 1 single- and multiple-ascending dose clinical studies. Omeros' inhibitor of MASP-3, the key activator of the alternative pathway of complement, is in clinical development for paroxysmal nocturnal hemoglobinuria and complement 3 glomerulopathy.