Nippon Shinyaku files for PAH drug selexipag approval in Japan

8 January 2016

Nippon Shinyaku Japanese drugmaker (TYO: 4516) has submitted the New Drug Application for selexipag (development code: NS-304) to the Ministry of Health, Labor and Welfare (MHLW) for the treatment of pulmonary arterial hypertension (PAH).

Selexipag was originally discovered and synthesized by Nippon Shinyaku and was jointly developed in Japan with the local subsidiary of Swiss biotech firm Actelion (SIX: ACTN), which has just launched the drug in the USA under the trade name Uptravi (The Pharma Letter January 5). Analysts at Barclays estimate peak sales for the new drug at about 2 billion Swiss francs ($2.02 billion).

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.

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