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# Breakthrough Designation for Omeros’ OMS721
- URL: https://www.fdaweb.com/breakthrough-designation-for-omeros-oms721/
- Published: 2018-04-26T12:00:00.000Z
- Updated: 2026-09-15T00:01:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141313

FDA has granted Omeros Corp. a breakthrough therapy designation for OMS721 for treating patients with high-risk hematopoietic stem cell transplant-associated thrombotic microangiopathy (TMA), specifically those patients who have persistent TMA despite modification of immunosuppressive therapy. This is the second breakthrough therapy drug designation for OMS721, which last year received one for treating Immunoglobulin A nephropathy. OMS721 is a human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2, the effector enzyme of the lectin pathway of the complement system.