Omeros BLA for Stem Cell Transplant Complication

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.