Launch of Uptravi® Tablet for the Treatment of Pulmonary Arterial Hypertension
Nippon Shinyaku Co., Ltd. (HQ: Kyoto, President: Shigenobu Maekawa) today announced that it has launched Uptravi® Tablets 0.2mg and 0.4mg (generic name: selexipag, development code: NS-304) for the treatment of pulmonary arterial hypertension (PAH). Uptravi® was originally discovered and synthesized by Nippon Shinyaku and was jointly developed in Japan with Actelion Pharmaceuticals Japan Ltd. (HQ: Tokyo, President: Satoshi Tanaka).
PAH is a disease with a poor prognosis, characterized by an abnormally increased blood pressure in the pulmonary artery 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 often includes three modes of action: prostacyclin receptor agonists, endothelin receptor antagonists (ERA) and phosphodiesterase 5 inhibitors (PDE5i).
Uptravi® is the first-in-class, orally active and selective IP prostacyclin receptor agonist. Our global partner Actelion Pharmaceuticals Ltd. established its efficacy, tolerability and safety based on the multinational phase 3 study (GRIPHON study*). Its safety and efficacy for Japanese patients were established by domestic clinical studies as well.
Nippon Shinyaku adds Uptravi® to its portfolio of PAH products, Opsumit® (ERA, originally discovered and synthesized by Actelion, and co-promoted with Actelion Pharmaceuticals Japan Ltd.) and Adcirca® (PDE5i), that it already promotes in Japan.
In Japan, Nippon Shinyaku will co-promote Uptravi® in collaboration with Actelion Pharmaceuticals Japan Ltd. Through close cooperation, we hope to contribute further to the improvement of PAH treatment in Japan by making Uptravi® available to the patients as soon as possible.
* GRIPHON study
The GRIPHON study was a randomized, multicenter, double-blind, placebo-controlled long-term event-driven clinical trial, designed to demonstrate a prolongation in time to the first morbidity or mortality event for Uptravi® compared to placebo, enrolling 1,156 patients from 39 countries. The exposure to Uptravi® was up to 4.2 years. The risk of a primary composite endpoint event of morbidity or mortality was reduced by 40% (p<0.001) with Uptravi® compared to placebo. The benefit of Uptravi® was consistent across pre-specified patient subgroups such as age, gender, PAH classification, WHO functional class, and use of medication for PAH, including patients receiving both an ERA and a PDE5i at baseline (n = 376; 32.5%).