FDA Grants Orphan Drug Designation to Omeros’ MASP-3 Inhibitor OMS906 for Treatment of Paroxysmal Nocturnal Hemoglobinuria
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Friday, July 29, 2022
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Omeros Corporation today announced that OMS906 has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH).
Key Points:
- Omeros Corporation today announced that OMS906 has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH).
- OMS906 targets mannan-binding lectin-associated serine protease-3 (MASP-3), the key activator of the alternative pathway of the complement system.
- FDA grants orphan designation to promote the development of a drug that is expected to have significant therapeutic advantage over existing treatments that target a condition affecting 200,000 or fewer U.S. patients annually.
- OMS906, Omeros inhibitor of MASP-3, the key activator of the alternative pathway of complement, is initiating Phase 1b clinical programs in paroxysmal nocturnal hemoglobinuria (PNH) and complement 3 glomerulopathy (C3G).