Nippon Shinyaku Submits NDA to MHLW for Selexipag for Treatment of Pulmonary Arterial Hypertension.

Nippon Shinyaku Co., Ltd. today announced the submission of the New Drug Application (NDA) for selexipag (development code: NS-304), which was originally discovered and synthesized by Nippon Shinyaku Co., Ltd. and was jointly developed in Japan with Actelion Pharmaceuticals Japan Ltd. (HQ: Tokyo, President: Satoshi Tanaka), to the Ministry of Health, Labor and Welfare (MHLW) for the treatment of pulmonary arterial hypertension (PAH).

 PAH is a disease with a poor-prognosis, characterized by an abnormally increased blood pressure in the pulmonary artery from any cause and is classified as either idiopathic PAH (PAH of unknown cause) or associated PAH (PAH secondary to certain diseases such as connective tissue disease and congenital heart disease). Treatment for PAH includes prostacyclin (PGI2) receptor agonists, endothelin receptor antagonists (ERA) and phosphodiesterase 5 inhibitors (PDE5i).

 Selexipag is an orally available, long-acting PGI2 receptor agonist which selectively targets the PGI2 receptor and shows long-term efficacy in PAH by inducing vasodilation and inhibiting proliferation of vascular smooth muscle cells.

 Our licensee, Actelion (Switzerland), conducted an international multicenter Phase III study (GRIPHON) which enrolled patients with PAH from worldwide study sites (ex-Japan) and, based on the excellent data of the GRIPHON study, received the NDA approval from the US FDA in December 2015. Uptravi became commercially available in the US as of January 4th, 2016.

 In Japan, Nippon Shinyaku and Actelion Pharmaceuticals Japan, Ltd. jointly conducted a Phase II study in which selexipag showed statistically significant improvement in pulmonary hemodynamics.

 In addition to marketing Opsumit (ERA) and Adcirca (PDE5i), Nippon Shinyaku hope to contribute further to the improvement of PAH treatment in Japan by making the novel PGI2 agonist, selexipag, available to the patients as soon as possible. In Japan , Opsumit and selexipag are co-promoted with Actelion Pharmaceuticals Japan Ltd.

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