Omeros receives positive opinion for OMS721 from EMA
Omeros Corporation announced that the European Medicines Agency's Committee for Orphan Medicinal Products issued a positive opinion on Omeros' application for orphan drug designation of OMS721 in the treatment of primary Immunoglobulin A nephropathy. 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, and is in Phase 3 development for each of IgAN, atypical hemolytic uremic syndrome, and hematopoietic stem cell transplant-associated thrombotic microangiopathy. The positive opinion issued by COMP is expected to be adopted by the European Commission at its February meeting. Orphan Drug Designation in Europe is available to companies developing products intended to treat a life-threatening or chronically debilitating condition that affects fewer than five in 10,000 persons in the European Union. This designation allows for financial and regulatory incentives that include a 10-year period of marketing exclusivity in the EU after product approval, protocol assistance from the EMA at reduced fees during the product development phase, and access to centralized marketing authorization. In August of 2017, the U.S. Food and Drug Administration granted orphan designation to OMS721 for the treatment of IgAN and, in June of 2017, FDA granted breakthrough therapy designation to OMS721 for IgAN. Omeros has requested from EMA Priority Medicines status for OMS721 in the treatment of IgAN.