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# Omeros BLA for Stem Cell Transplant Complication
- URL: https://www.fdaweb.com/omeros-bla-for-stem-cell-transplant-complication/
- Published: 2021-01-19T12:00:00.000Z
- Updated: 2026-09-14T16:43:12.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5148481

FDA has accepted for priority review an Omeros BLA for narsoplimab for treating hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). HSCT-TMA is a significant and often lethal complication of stem cell transplantation. “This condition is a systemic, multifactorial disorder caused by endothelial cell damage induced by conditioning regimens, immunosuppressant therapies, infection, graft-versus-host disease, and other factors associated with stem cell transplantation,” the company says. “Endothelial damage, which activates the lectin pathway of complement, plays a central role in the development of HSCT-TMA,” it says. Narsoplimab is designed to target mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway of complement. The agency has set a 7/17 review action target date for the submission.