NS Pharma, Inc. (NS Pharma), a subsidiary of Japan-based Nippon Shinyaku Co., Ltd, announced on Monday that it has received orphan drug designation from the European Commission (EC) for NS-229, intended for the treatment of the rare disease eosinophilic granulomatosis with polyangiitis (EGPA), an autoimmune disease that is serious and life-threatening with unmet medical need.
The EC orphan drug designation is issued for drugs which are intended to treat diseases that affect fewer than five in 10,000 people in the European Union and are life-threatening or chronically debilitating. The Orphan Drug Designation provides NS Pharma with a ten-year marketing exclusivity period, supporting the company's continued development and evaluation of this therapy.
NS-229 is a potent and selective Janus kinase (JAK) 1 inhibitor, developed in-house, which suppresses excessive activation of T cells, B cells and certain white blood cells. As a result, it is anticipated that NS-229 could reduce tissue damage and curb various symptoms of EGPA. A Phase II global study of NS-229 is scheduled to be conducted by NS Pharma.
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