Pharma Focus Europe

The European Commission Has Granted Orphan Drug Designation to NS-229 for the Treatment of Eosinophilic Granulomatosis With Polyangiitis

Tuesday, January 23, 2024

NS Pharma, Inc., a subsidiary of Nippon Shinyaku Co., Ltd, has received orphan drug designation from the European Commission (EC) for NS-229, a drug under development to treat the rare disease eosinophilic granulomatosis with polyangiitis (EGPA). The orphan drug designation is granted for drugs intended to address diseases affecting fewer than five in 10,000 people in the European Union that are life-threatening or chronically debilitating. This designation provides NS Pharma with a ten-year marketing exclusivity period, supporting the ongoing development and evaluation of NS-229.

EGPA is an autoimmune disease typically preceded by symptoms of bronchial asthma and allergic rhinitis. The inflammation in small blood vessels can lead to damage in various organs and tissues, such as the lungs, sinuses, peripheral nerves, skin, and kidneys. The cause of EGPA remains unknown.

NS-229, a Janus kinase (JAK) 1 inhibitor developed by NS Pharma, is a potent and selective treatment that suppresses excessive activation of T cells, B cells, and certain white blood cells. It is anticipated that NS-229 could mitigate tissue damage and alleviate various symptoms of EGPA. NS Pharma is set to conduct a Phase II global study of NS-229 as part of its ongoing efforts to address the unmet medical needs of EGPA patients.

Takeshi Seita, Vice President of Research & Development at NS Pharma, expressed optimism about advancing the innovative therapy for the treatment of EGPA, acknowledging the severity and life-threatening nature of the disease and emphasizing the company's commitment to meeting the needs of affected patients.



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