NS Pharma Inc, a subsidiary of Japan-based Nippon Shinyaku Co Ltd (TYO:4516), announced on Monday that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation to NS-229, which is being developed for the treatment of eosinophilic granulomatosis with polyangiitis (EGPA).
A rare autoimmune disease, EGPA causes inflammation in small-to-medium-sized blood vessels which can cause tissue and organ damage to the lungs, sinuses, peripheral nerves, skin and kidneys.
NS-229 is being investigated as a selective Janus kinase 1 (JAK1) inhibitor to help regulate immune cell function and prevent the immune system from causing tissue damage.
FDA Orphan Drug Designation status is granted for treatments of rare diseases affecting fewer than 200,000 people in the United States. This designation provides NS Pharma with a seven-year market exclusivity period, in support of the company's continued development and evaluation of this therapy.
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