BAYER FILES FOR JAPAN APPROVAL FOR RIOCIGUAT FOR CTEPH (ENG)
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Not intended for U.S. and UK Media Bayer Submits Investigational Drug Riociguat for Patients with Chronic Thromboembolic Pulmonary Hypertension for Regulatory Approval in Japan
Berlin, May 17, 2013 - Bayer HealthCare has filed the oral investigational drug riociguat for the treatment of chronic thromboembolic pulmonary hypertension (CTEPH) for regulatory approval in Japan. CTEPH is a progressive and life-threatening disease in which it is believed that blood clots of pulmonary vessels gradually lead to an increased pressure in the pulmonary arteries, resulting in an overload of the right heart.
"To date, there is no pharmacological treatment available for CTEPH. There is an urgent unmet medical need for patients for whom surgery is not a viable treatment option or whose disease persists or is recurrent after surgery," said Kemal Malik, member of the Bayer HealthCare Executive Committee and Head of Global Development. "We hope to be able to bring riociguat to doctors and patients of this life-threatening disease in Japan soon."
Riociguat is the first drug therapy that has shown clinical efficacy in the treatment of inoperable CTEPH patients, or patients with persistent or recurrent CTEPH after surgery. The submission is supported by data from the randomized, double-blind, placebo-controlled pivotal, global Phase III study CHEST-1. Results of the study were presented at the 2012 annual meeting of the American College of Chest Physicians (ACCP) in Atlanta, USA. Within CHEST-1 the primary endpoint, a change in exercise capacity, was reached after 16 weeks: Compared to placebo, patients treated with riociguat showed a statistically significant improvement (p<0.0001) from baseline in the six-minute walk test (6MWT) after this time frame. Riociguat was generally well tolerated, with a good safety profile.
Bayer HealthCare announced positive results of an interim analysis of the on-going CHEST-2 trial, the open-label long-term extension of the pivotal Phase III study CHEST-1 with riociguat at the 5th World Symposium of Pulmonary Hypertension (WSPH) in Nice, France. The interim analysis shows long-term safety and sustained clinical benefits in patients with inoperable CTEPH.
At the beginning of February, Bayer HealthCare submitted riociguat, the first drug to demonstrate efficacy in two distinct forms of pulmonary hypertension, namely inoperable CTEPH and pulmonary arterial hypertension (PAH) for regulatory approval in the United States and in the European Union. In April, the U.S. Food and Drug Administration (FDA) granted priority review to the New Drug Application (NDA) in both indications.
Riociguat was discovered by Bayer and represents the first member of a novel class of compounds, the stimulators of soluble guanylate cyclase (sGC).
About Pulmonary Hypertension Pulmonary hypertension (PH) is a severe, progressive and life-threatening disorder in which the pressure in the pulmonary arteries is significantly increased and which can lead to heart failure and death. Patients with PH develop a markedly decreased exercise tolerance and reduced quality of life. The most common symptoms of PH include shortness of breath, fatigue, dizziness and fainting, all of which are worsened by exertion. As the symptoms of PH are non-specific, diagnosis can be delayed by as much as two years. Early diagnosis is essential as a delay in treatment initiation can have a negative impact on survival. Continuous treatment monitoring is then vital to ensure that patients are receiving optimal care for their particular type and stage of disease.
According to the clinical classification of PH (Dana Point), there are five different types of PH based on underlying causes which are: pulmonary arterial hypertension (PAH), pulmonary hypertension owing to left heart disease (e.g. PH-LVD), pulmonary hypertension owing to lung disease and/or hypoxemia (e.g. PH-COPD or PH-ILD), chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary hypertension with unclear multifactorial mechanisms. Currently available pharmacological treatments are only approved to treat one of the five types of PH, pulmonary arterial hypertension. As a result, there is a strong need for more research to improve understanding of how all five types of PH can be treated effectively.
About Chronic Thromboembolic Pulmonary Hypertension (CTEPH) CTEPH is a rare and life-threatening disease in which it is believed that thromboembolic occlusion (blood clots) of pulmonary vessels gradually lead to an increased pressure in the pulmonary arteries, resulting in an overload of the right heart. CTEPH may evolve after prior episodes of acute pulmonary embolism, but the pathogenesis is not yet completely understood. The standard treatment for CTEPH is pulmonary endarterectomy (PEA), a surgical procedure in which the blood vessels of the lungs are cleared of clot and scar material. However, a considerable number of patients with CTEPH are not operable and in some patients the disease persists or reoccurs after PEA. Currently, there are no approved pharmacological treatments available for CTEPH.
About Riociguat Riociguat (BAY 63-2521) is a soluble guanylate cyclase (sGC) stimulator, the first member of a novel class of compounds being investigated as a new and specific approach to treat different types of PH. sGC is an enzyme found in the cardiopulmonary system and the receptor for nitric oxide (NO). When NO binds to sGC, the enzyme enhances synthesis of the signaling molecule cyclic guanosine monophosphate (cGMP). cGMP plays an important role in regulating vascular tone, proliferation, fibrosis, and inflammation.
PH is associated with endothelial dysfunction, impaired synthesis of NO and insufficient stimulation of sGC. Riociguat has a unique mode of action - it sensitizes sGC to endogenous NO by stabilizing the NO-sGC binding. Riociguat also directly stimulates sGC via a different binding site, independently of NO. Riociguat, as a stimulator of sGC, addresses NO deficiency by restoring the NO-sGC-cGMP pathway, leading to increased generation of cGMP.
With its novel mode of action, Riociguat has the potential to overcome a number of limitations of currently approved PAH therapies, including NO dependence, and is the first drug which has shown clinical benefits in CTEPH, where no pharmacological treatment is approved.
About Bayer HealthCare The Bayer Group is a global enterprise with core competencies in the fields of health care, agriculture and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 18.6 billion (2012), is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare’s aim is to discover, develop, manufacture and market products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 55,300 employees (Dec 31, 2012) and is represented in more than 100 countries. More information at http://www.healthcare.bayer.com.
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