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Narsoplimab FDA Approval Status

Last updated by Judith Stewart, BPharm on Oct 3, 2021.

FDA Approved: No
Generic name: narsoplimab
Company: Omeros Corporation
Treatment for: Hematopoietic Stem Cell Transplant-Associated Thrombotic Microangiopathy (HSCT-TMA)

Narsoplimab is an investigational human monoclonal antibody in development for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).

  • Hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) is a significant and often lethal complication of stem cell transplantation. HSCT-TMA 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.
  • Narsoplimab works by targeting mannan-binding lectin-associated serine protease-2 (MASP-2), a novel pro-inflammatory protein target and the effector enzyme of the lectin pathway of complement. 
  • A biologics license application (BLA) has been submitted to the U.S. FDA for use of narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA), and the drug is in Phase 3 clinical programs for immunoglobulin A (IgA) nephropathy and atypical hemolytic uremic syndrome (aHUS).
  • The FDA has granted narsoplimab breakthrough therapy designations for HSCT-TMA and for IgA nephropathy; orphan drug status for the prevention (inhibition) of complement-mediated thrombotic microangiopathies, for the treatment of HSCT-TMA and for the treatment of IgA nephropathy; and fast track designation for the treatment of patients with atypical hemolytic uremic syndrome (aHUS).

Development timeline for narsoplimab

DateArticle
Oct 18, 2021Omeros Receives Complete Response Letter from FDA for Biologics License Application for Narsoplimab in the Treatment of HSCT-TMA
Oct  1, 2021Omeros Provides Regulatory Update on Biologics License Application for Narsoplimab in the Treatment of HSCT-TMA
May 20, 2021Omeros Announces Extension of FDA Review Period for Narsoplimab in HSCT-TMA
Jan 19, 2021Biologics License Application for Narsoplimab in HSCT-TMA Accepted for Priority Review by U.S. FDA
Nov 18, 2020Omeros Submits its Biologics License Application to U.S. FDA for Narsoplimab in HSCT-TMA

Further information

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