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FDA Grants Orphan Drug Designation to Omeros’ OMS721 for Treatment of IgA Nephropathy

Omeros Corporation (OMER) today announced that OMS721 has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of Immunoglobulin A (IgA) nephropathy. OMS721 is Omeros’ lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway of the complement system. IgA nephropathy is the most common primary glomerulopathy globally, with an estimated 120,000 to 180,000 cases in the U.S. alone, and accounts for up to 10 percent of all dialysis patients. Up to 40 percent of individuals with the disease develop end-stage renal disease, a life-threatening condition, within 20 years following diagnosis.

As previously reported, Phase 2 clinical trial results with OMS721 in IgA nephropathy patients show unprecedented reductions in urine protein levels during and following treatment with OMS721. Elevated urinary protein is highly correlated with poor outcomes in patients with IgA nephropathy. Following review of these data, FDA in June granted OMS721 breakthrough therapy designation for the treatment of IgA nephropathy. Omeros plans to begin enrolling patients in its Phase 3 registration trial in IgA nephropathy later this year.

“Working with FDA, we are initiating another Phase 3 program for OMS721 – this one in IgA nephropathy, which has been granted both breakthrough and orphan designations,” stated Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. “This marks the second Phase 3 program for...


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