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FDA grants fast track status to OMS721 for atypical hemolytic uremic syndrome
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The FDA today granted fast track status to OMS721 — a complement inhibitor — for the treatment of patients with atypical hemolytic uremic syndrome, according to a press release from the drug’s manufacturer.
OMS721 (Omeros) is a human monoclonal antibody that targets mannan-binding lectin-associated serine protease-2. OMS721 is the key regulator of the immune system’s lectin pathway.
Omeros is currently evaluating OMS721 in a phase 2 clinical trial in patients with atypical hemolytic uremic syndrome and other thrombotic microangiopathies, including thrombotic thrombocytopenic purpura.
The trial is being conducted in multiple sites throughout the United States and Europe. To date, most patients enrolled in the trial were diagnosed with thrombotic microangiopathies.
Earlier in 2015, Omeros announced positive data from the phase 2 trial, according to the press release.
In addition, Omeros announced the beginning of an investigator-requested compassionate use program for OMS721, which would allow extended treatment of patients who completed the trial's four-week dosing.
OMS721 previously received orphan drug designation from the FDA.
"FDA's Fast Track designation of OMS721 for [atypical hemolytic uremic syndrome] reflects the unmet need associated with this disease and recognizes the drug's potential as an important option for the treatment of [atypical hemolytic uremic syndrome]," Gregory A. Demopulos, MD, chairman and chief executive officer of Omeros, said in a press release. "We look forward to working with the FDA to streamline the development of this promising drug, and we currently remain on track to discuss with the agency later this year both the data from our Phase 2 trial in [thrombotic microangiopathies] as well as our plans for our Phase 3 program."