Bayer HealthCare Registers Riociguat Regulatory Clearance In Japan for PAH

Bayer HealthCare, a subsidiary of German-owned corporation, Bayer AG, has just announced that it has registered its therapeutic drug Riociguat for regulatory clearance in Japan. The drug has gone through intensive clinical research and development under Bayer, and is eyeing becoming the next novel treatment of two types of pulmonary hypertension: chronic thromboembolic pulmonary hypertension (CTEPH) and Pulmonary Arterial Hypertension (PAH).

According to a press release, Bayer’s move to secure regulatory approval in Japan proceeds the company’s findings from a “randomized, double-blind, placebo-controlled, global Phase III study PATENT-1 as well as long-term data from PATENT-2”. These studies evaluated the oral form of the drug’s effectiveness and reliability in treating PAH. The first study was able to confirm a statistically remarkable betterment from baseline data, based on a six-minute walk test or 6MWT, which serves as a guide to determining the disease progression and survival rate.

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Earlier this year, in January, Japan’s Ministry of Health, Labour and Welfare (MHLW) authorized riociguat under the brand name Adempas for the treatment of CTEPH.

Pulmonary Arterial Hypertension is a form of pulmonary hypertension wherein there is a dangerous increase in blood pressure within the arteries of the lungs. When the pulmonary arteries constrict, the heart has to exert more effort to pump blood into the constricted vasculature. Over time, this strains the heart, eventually causing cardiac hypertrophy and life-threatening congestive heart failure. Presently, there is no known cure for PAH.

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