Both Phase III studies with riociguat bbq concession trailers the primary endpoint, an improvement

"We are very pleased with the CHMP recommendation for approval of riociguat, and we look forward to, approval bbq concession trailers by the European Commission, do get this drug to patients with these rare, serious and life-threatening diseases," said Kemal Malik (MB, BS) , Member of the Bayer HealthCare Executive Committee and Head of Global Development
The European Committee for Medicinal Products for Human Use (CHMP) recommended approval of riociguat tablet for use in two forms of pulmonary hypertension, a group of progressive diseases that put the patient's life at risk: the treatment of adult patients with thromboembolic pulmonary hypertension chronic (HPTEC) inoperable, recurrent or persistent after surgical treatment, to improve bbq concession trailers exercise capacity, and treatment of adult patients with pulmonary arterial hypertension (PAH) to improve exercise capacity. Riociguat is the first of a new class of drugs, stimulators of soluble guanylate cyclase (sGC). Your new mode of action was developed to achieve bbq concession trailers an underlying molecular mechanism pulmonary hypertension key. The final European Commission decision bbq concession trailers on approval is expected in the first half of 2014.
"We are very pleased with the CHMP recommendation for approval of riociguat, and we look forward to, approval by the European Commission, do get this drug to patients with these rare, serious and life-threatening diseases," bbq concession trailers said Kemal Malik (MB, BS) , Member of the Bayer HealthCare Executive Committee and Head of Global Development.
"Riociguat is the first drug to demonstrate efficacy bbq concession trailers in two forms of pulmonary hypertension, PAH and HPTEC. For HPTEC, pulmonary bbq concession trailers endarterectomy is the primary treatment option and potentially curative. There are, to date, drug therapy bbq concession trailers approved in the European Union - however, a considerable number bbq concession trailers of patients with HPTEC are not operable, and in up to 35% of operated patients, the disease can persist bbq concession trailers or recur. "
"The consistency and robustness of the positive results of clinical trials CHEST and PATENT are substantial: the riociguat demonstrated significant and sustained clinical efficacy and safety in patients with PAH treatment-naïve and pretreated patients with endothelin receptor antagonists (ERAs) or prostanoid with monotherapy, and in patients with inoperable or HPTEC persistent or recurrent after surgery HPTEC. So far, no other pharmacological treatment showed significant effect on HPTEC "said Ardeschir Ghofrani, bbq concession trailers Principal Investigator and Professor at the University Hospital of Giessen and Marburg, Germany. "For patients in both groups, and HAP HPTEC as well as their doctors, treatment with riociguat allowed the observation of high relevance in many of the objectives set for tests such as the 6-minute test running clinical improvements, cardiopulmonary hemodynamics, WHO Functional Class, and a biomarker associated with the disease. "
The CHMP recommendation is based on the results of two global phase III double-blind, randomized, controlled CHEST-1 and PATENT-1 placebo, as well as the interim results bbq concession trailers available at the time of testing long-term extension CHEST - PATENT-2 and 2. These assessed bbq concession trailers the efficacy bbq concession trailers and safety of oral riociguat in the treatment of PAH and HPTEC respectively. HPTEC and PAH are two rare and potentially fatal forms of pulmonary hypertension characterized by a significant increase in the pressure in the pulmonary arteries.
Both Phase III studies with riociguat bbq concession trailers the primary endpoint, an improvement in exercise capacity after 16 and 12 weeks, respectively. The riociguat also showed consistent improvements in several relevant secondary bbq concession trailers endpoints and was generally bbq concession trailers well tolerated with a good safety profile. The results of both trials were published in the New England Journal of Medicine (NEJM) in July 2013. The program development phase III PATENT CHEST and testing continues with the long-term extension, chest-PATENT-2 and 2 showing the first interim analysis, a good safety profile and sustained efficacy over a year. The most frequently reported adverse reactions occurring in 10% of patients treated with riociguat (up to 2.5 mg three times daily) were headache, dizziness, dyspepsia, peripheral edema, nausea, diarrhea and vomiting.
The riociguat was approved in the U.S. for use in HPTEC and PAHs in October 2013, Canada and Switzerland in indicating HPTEC in September and November 2013 and in Japan in HPTEC in January 2014. In February 2013, Bayer HealthCare submitted regulatory approval for the riociguat in the European Union, in both directions.
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