Bayer's Investigational Riociguat Granted U.S. FDA Priority Review For Pulmonary Arterial Hypertension And Inoperable Or Persistent/Recurrent Chronic Thromboembolic Pulmonary Hypertension
About PATENT PATENT (Pulmonary Arterial Hypertension sGC-Stimulator Trial) is a Phase III trial to assess oral riociguat in the treatment of treatment naive patient and pre-treated patients with symptomatic PAH. PATENT is a multi-center, multi-national program with active centers in 32 countries. The program includes a randomized, double-blind, placebo controlled trial phase (PATENT-1) and an open label extension trial phase (PATENT-2).
In the PATENT-1 study, 445 patients with symptomatic PAH were randomized to receive either placebo or two different doses of riociguat orally over a period of 12 weeks. The primary endpoint of the trial was improvement in 6-minute walking distance. The riociguat dose was titrated, over a period of eight weeks in doses of 0.5 mg increments from 1.0 mg up to 2.5 mg three times daily. Patients were then followed for an additional four weeks to complete the study. Patients then had the option of participating in the open label extension study, after completing an eight-week blinded sham titration.
About Riociguat Riociguat (BAY 63-2521), discovered and developed at the Bayer research laboratories, is an investigational oral soluble guanylate cyclase (sGC) stimulator that is being studied in CTEPH and PAH, as well as other forms of pulmonary hypertension. Riociguat is an investigational agent and is not approved by the FDA, EMA or other health authorities.
About Bayer HealthCare Pharmaceuticals Inc. Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of Bayer AG. Bayer HealthCare is one of the world's leading, innovative companies in the healthcare and medical products industry, and combines the activities of the Animal Health, Consumer Care, Medical Care, and Pharmaceuticals divisions. As a specialty pharmaceutical company, Bayer HealthCare provides products for General Medicine, Hematology, Neurology, Oncology and Women's Healthcare. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.Bayer ® and the Bayer Cross ® are registered trademarks of Bayer. Forward-Looking Statement This news release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. Intended for U.S. media only SOURCE Bayer HealthCare
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