Launch of Opsumit® Tablet 10 mg for the treatment of pulmonary arterial hypertension.
Nippon Shinyaku Co., Ltd. and Actelion Pharmaceuticals Japan Ltd. (Headquarters: Tokyo, Japan; President: Satoshi Tanaka; “Actelion Japan”) announced today the launch of “Opsumit® Tablet 10 mg” onto the Japanese Market. Opsumit® (Macitentan) Tablet has been developed jointly by Actelion Japan and Nippon Shinyaku. Actelion Japan received marketing approval for Opsumit® for the treatment of pulmonary arterial hypertension in Japan in March 2015.
Opsumit® is an endothelin receptor antagonist. In the global Phase III SERAPHIN study, treatment with macitentan 10mg once a day resulted in 45% risk reduction (p<0.0001) of the composite morbidity-mortality endpoint when compared to placebo. Improvements in pulmonary vascular resistance, 6MWD, and WHO functional class were observed in a local clinical study conducted in Japan.
PAH treatments currently available in Japan are classified into three different classes of drugs (PDE5 inhibitors, IP receptor agonists, and endothelin receptor antagonists). With the launch of Opsumit®, Nippon Shinyaku will have products of these three classes in its portfolio along with “Adcirca® Tablet 20mg”(launched) and NS-304 (selexipag, under development).
Actelion Japan will market and distribute the product in Japan, while Actelion Japan and Nippon Shinyaku will co-promote the product. Nippon Shinyaku is hopeful that the PAH patients and their family will benefit from wider treatment options for their difficult-to-treat disease. Both companies will work together to make Opsumit® available in clinical practice in Japan as soon as possible.