SEATTLE--(BUSINESS WIRE)--Omeros Corporation (Nasdaq: OMER) today announced that the Centers for Disease Control and Prevention (CDC) has approved an International Classification of Diseases (ICD-10) diagnosis code, M31.11 – hematopoietic stem cell transplantation-associated thrombotic microangiopathy (HSCT-TMA). The absence of a specific HSCT-TMA diagnosis code has led to underreporting of diagnoses and inaccurate coding, which has complicated reporting of the incidence and outcomes of the disease. This new ICD-10 code, which will be effective October 1, 2021, will for the first time allow clinicians, payers and others to accurately track the incidence of HSCT-TMA. Additional instructions about how to report the code will be available from the CDC later this year.
Separately, the Centers for Medicare & Medicaid Services (CMS) has approved two ICD-10-PCS codes for the administration of narsoplimab: XW03357 – Introduction of Narsoplimab Monoclonal Antibody into Peripheral Vein, and XW04357 – Introduction of Narsoplimab Monoclonal Antibody into Central Vein, Percutaneous Approach, New Technology Group 7. ICD-10-PCS codes are used by billers to identify procedures and services performed during an inpatient stay. These new procedure codes will also be effective October 1, 2021. The new codes will be essential to facilitating billing and reimbursement and for tracking utilization, if narsoplimab is approved by the U.S. Food and Drug Administration (FDA). Additional instructions about how to report the code will be available from CMS later this year, and providers should consult their payers for guidance on use of the codes.
Narsoplimab, also known as “OMS721,” is an investigational human monoclonal antibody 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. Importantly, inhibition of MASP-2 does not appear to interfere with the antibody-dependent classical complement activation pathway, which is a critical component of the acquired immune response to infection. Omeros controls the worldwide rights to MASP-2 and all therapeutics targeting MASP-2.
A biologics license application (BLA) is under priority review by 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 aHUS. The European Medicines Agency has granted orphan drug designation to narsoplimab for treatment in HSCT and for treatment of primary IgA nephropathy.
About Omeros Corporation
Omeros is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting inflammation, complement-mediated diseases, disorders of the central nervous system and immune-related diseases, including cancers. Its commercial product OMIDRIA (phenylephrine and ketorolac intraocular solution) 1%/0.3% continues to gain market share in cataract surgery. Omeros’ lead MASP-2 inhibitor narsoplimab targets the lectin pathway of complement and is the subject of a biologics license application under priority review by FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. Narsoplimab is also in multiple late-stage clinical development programs focused on other complement-mediated disorders, including IgA nephropathy, atypical hemolytic uremic syndrome and COVID-19. Omeros’ MASP-3 inhibitor OMS906, which targets the complement system’s alternative pathway, recently entered the clinic, and the company’s PDE7 inhibitor OMS527 has successfully completed its Phase 1 trial. Omeros’ pipeline holds a diverse group of preclinical programs including a novel antibody-generating technology and a proprietary GPCR platform through which it controls 54 new GPCR drug targets and their corresponding compounds. One of these novel targets, GPR174, modulates a new cancer immunity axis recently discovered by Omeros, and the company is advancing small-molecule GPR174 inhibitors. For more information about Omeros and its programs, visit www.omeros.com.
Forward Looking Statements
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