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Omeros Corporation (NASDAQ:OMER) today announced the publication of a peer-reviewed manuscript in the American Journal of Hematology detailing survival outcomes in adult and pediatric patients with life-threatening transplant-associated thrombotic microangiopathy (TA-TMA) treated with narsoplimab through a global expanded access program (EAP). Narsoplimab inhibits MASP-2, the effector enzyme of the lectin pathway of complement, and is currently under review for marketing approval by both the U.S. FDA and the European Medicines Agency.
Authored by an international panel of pediatric and adult transplant experts, the manuscript – titled "Narsoplimab Results in Excellent Survival in Adults and Children with Hematopoietic Cell Transplant Associated Thrombotic Microangiopathy (TA-TMA)" – reports survival outcomes in patients treated with narsoplimab as first-line therapy and in those who failed prior treatments, including C5 inhibitors. Consistent with previous narsoplimab clinical studies, no safety signals of concern were observed. The full manuscript is available online.
About Narsoplimab
Narsoplimab (OMS721) is an investigational, fully human monoclonal antibody that inhibits mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway of complement. Unlike other complement inhibitors, narsoplimab preserves the lytic function of the classical pathway, which is critical for antibody-mediated immune defense against infection.
A biologics license application (BLA) for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) is currently under review by the FDA, and a corresponding marketing authorisation application (MAA) is under review by the European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use. Narsoplimab has received breakthrough therapy and orphan drug designations from the FDA for TA-TMA and for the prevention (inhibition) of complement-mediated thrombotic microangiopathies. The EMA has granted orphan drug designation for narsoplimab in hematopoietic stem-cell transplant.
Posted In: OMER
