Johnson & Johnson and Nippon Shinyaku Gain Japan Approval for Opsumit in Pediatric Pulmonary Arterial Hypertension

Reuters12-22 14:35

Johnson & Johnson and Nippon Shinyaku Gain Japan Approval for Opsumit in Pediatric Pulmonary Arterial Hypertension

Johnson & Johnson has received approval from Japan's Ministry of Health, Labor and Welfare for Opsumit® (macitentan) tablets 10 mg for the additional indication of pediatric pulmonary arterial hypertension (PAH), as well as for Opsumit® Pediatric Dispersible Tablets in 1.0 mg and 2.5 mg doses for patients aged three months and older. This regulatory approval was supported by data from global and local clinical studies and will be jointly promoted in Japan in collaboration with Nippon Shinyaku Co. Ltd.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Nippon Shinyaku Co. Ltd. published the original content used to generate this news brief on December 22, 2025, and is solely responsible for the information contained therein.

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