Omeros Corporation announced on June 27, 2025, the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for narsoplimab. This application is 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, demonstrating a 61% response rate and a three-fold improvement in overall survival compared to a well-matched external control group. The submission also incorporates outcomes from over 130 TA-TMA patients treated under Omeros’ expanded access program.
Narsoplimab has been granted orphan drug designation by the EMA, allowing for review through the centralized procedure, which covers all EU member states and European Economic Area countries. The review procedure is expected to begin in mid-July, with a final decision anticipated in mid-2026.
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