The FINANCIAL — Adempas (riociguat) has received approval for the treatment of patients with pulmonary arterial hypertension (PAH) by the Ministry of Health, Labour and Welfare (MHLW) in Japan, according to Bayer.
Following the approval of Adempas in January 2014 for the treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH) or persistent or recurrent CTEPH after surgery, Adempas is now the first drug approved in Japan to treat two forms of pulmonary hypertension (PH). The development and commercialization of riociguat is part of the worldwide strategic collaboration with Merck (through a subsidiary) in the field of soluble guanylate cyclase (sGC) modulation. Merck is known as MSD outside of the U.S. and Canada.
“PAH is a rare disease that usually presents with symptoms such as breathlessness, dizziness and fainting. It severely impacts patients’ daily lives, and if untreated, PAH may be fatal,” said Norifumi Nakanishi, M.D., Ph.D., Director of Endowed Department of Pulmonary Hypertension and Pulmonary Vascular Medicine, National Cerebral and Cardiovascular Center Research Institute, Osaka, Japan. “Physicians have been awaiting the approval of Adempas in PAH as an additional indication. With its novel mode of action, we expect Adempas may improve the symptoms of many patients with PAH whose prognosis has remained poor despite the availability of several approved PAH therapies.”
“In the pivotal PATENT-1 Phase III trial, riociguat demonstrated significant clinical efficacy across multiple clinically relevant endpoints in patients with PAH, either as a monotherapy or in combination with certain other medicines used to treat PAH, such as endothelin receptor antagonists (ERAs) or prostanoids,” said Dr. Joerg Moeller, Member of the Bayer HealthCare Executive Committee and Head of Global Development. “Riociguat is an important new treatment option for patients with PAH.”
The approval of Adempas is based on results from the randomized, double-blind, placebo-controlled, global Phase III study PATENT-1 as well as long-term data from PATENT-2 available at the time. These assessed the efficacy and safety of oral riociguat in the treatment of PAH. Results of PATENT-1 were published in the New England Journal of Medicine (NEJM) in July 2013. One-year data from the open-label long-term extension study PATENT-2 published in the European Respiratory Journal demonstrate that the significant improvement in exercise capacity was further improved, whilst the safety profile was sustained and confirmed. An analysis of the PATENT-2 two-year data cut-off confirmed the sustained improvements in patients with PAH after two years of treatment with riociguat.
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