Omeros announced that the European Commission has adopted a decision designating OMS721 as an Orphan Medicinal Product in the European Union for treatment in hematopoietic stem cell transplantation, or HSCT. The adoption by the EC follows a positive opinion for orphan designation of OMS721 in this indication by the European Medicines Agency’s Committee for Orphan Medicinal Products. OMS721 is Omeros’ lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2, the effector enzyme of the lectin pathway of the complement system. There are three Phase 3 development programs ongoing with OMS721 in each of HSCT-associated thrombotic microangiopathy, atypical hemolytic uremic syndrome, and immunoglobulin A nephropathy.
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