Bayer Files For Approval Of Riociguat For PAH In Japan
Bayer HealthCare announced that it has filed for regulatory approval in Japan for riociguat for the treatment of patients with pulmonary arterial hypertension (PAH). Bayer has previously secured approval for riociguat under the brand name Adempas in chronic thromboembolic pulmonary hypertension (CTEPH) in Japan.
Riociguat is a soluble guanylate cyclase (sGC) stimulator and the first member of a novel class of compounds discovered and developed by Bayer as an oral treatment to target a key molecular mechanism underlying pulmonary hypertension. The compound is being investigated as a new and specific approach in the treatment of different types of pulmonary hypertension. The company said riociguat has the potential to overcome several limitations of currently approved PAH therapies such as nitric oxide dependence.
Dr. Jörg Möller, Member of the Bayer HealthCare Executive Committee and Head of Global Development, said, “In the pivotal Phase III clinical trial, PAH patients who received riociguat observed rapid and significant improvements with regard to the severity of their disease and to their symptoms. Moreover, these improvements were sustained over the long-term. Effective therapeutic options are needed in the treatment of a progressive disease where mortality remains high in spite of several drugs already available, so we hope to be able to bring riociguat to PAH patients and their treating physicians in Japan soon.”
Pulmonary hypertension (PH) is a severe, life-threatening, and progressive lung and heart disorder where the blood pressure in the pulmonary arteries is above normal and can lead to heart failure and death. Pulmonary arterial hypertension (PAH) is one of the five types of PH and is a progressive, life-threatening disease where blood pressure in the pulmonary arteries is increased due to vasoconstriction. Similar to PH, PAH can lead to heart failure and death.
The submission of riociguat for regulatory approval in Japan is based on results from the double-blind, placebo-controlled, randomized, global Phase III study PATENT-1 and long term data from PATENT-2 trial assessing the safety and efficacy of oral riociguat in the treatment of PAH.