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Bayer Files Riociguat For Regulatory Approval In Japan To Treat PAH

Bayer HealthCare, a subgroup of German conglomerate Bayer AG (BYR.L,BAYRY.PK,BAYZF.PK), said Wednesday that it has filed riociguat for the treatment of pulmonary arterial hypertension or PAH for regulatory approval in Japan.

The submission of riociguat in PAH in Japan 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. The PATENT-1 study met its primary endpoint by demonstrating a statistically significant improvement (p<0.0001) from baseline in the six-minute walk test (6MWT), a marker of disease severity and predictor of survival, after 12 weeks compared with placebo.

PAH is a progressive and life-threatening form of pulmonary hypertension in which the blood pressure in the pulmonary arteries is significantly increased due to vasoconstriction and which can lead to heart failure and death.

In January 2014, the MHLW in Japan had approved riociguat under the trade name Adempas in another life-threatening form of pulmonary hypertension, namely chronic thromboembolic pulmonary hypertension or CTEPH.

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