Omeros Corporation’s lead therapy candidate, OMS721, being developed for the treatment of complement- and inflammation-related disorders including atypical hemolytic uremic syndrome (aHUS), will now be known as narsoplimab, the company announced.
The generic name narsoplimab was approved by the United States Adopted Names (USAN) Council in consultation with the World Health Organization’s International Nonproprietary Names (INN) Expert Committee.
The joint work of the USAN and INN committees is intended to standardize therapy nomenclature worldwide so all related information is communicated accurately and clearly.
Omeros is now ensuring that all the requirements for the commercialization of OMS721 are in order. The adoption of a generic name for OMS721 is a critical step for final approval and achieving its marketing goal.
The company is planning to first request the approval of narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA), and later on for other indications that include aHUS and immunoglobulin A nephropathy. It has already started preparing a biologics license application to submit to the U.S. Food and Drug Administration, and a marketing authorization application for the European Medicines Agency.
Narsoplimab is a human monoclonal antibody that was specifically designed to block the activity of the MASP-2 enzyme. Inhibition of this enzyme is believed to prevent the activation of the complement pathways of the immune system, preventing the underlying mechanisms involved in aHUS and other immune-related disorders.
The aHUS trial is currently recruiting participants for a total of approximately 80 adults and adolescents with confirmed aHUS. Patients will receive a loading dose of narsoplimab intravenously (injection into the vein), followed by daily injections of the treatment.
Based on requests from treating physicians, Omeros has established a compassionate-use program for narsoplimab (NCT02355782), which is currently active in both the United States and Europe.
The program is available to patients with thrombotic microangiopathies who have participated in the ongoing Phase 2 trial (NCT02222545) of narsoplimab and have experienced significant improvements or achieved disease control with the treatment. This trial is still recruiting participants at 29 sites worldwide.
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