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FDA Reviewers Recommend Approval Of Bayer AG’s Hypertension Drug After Positive Trial Results-Reuters


Friday, 2 Aug 2013 12:06pm EDT 

Reuters reported that Bayer AG's drug to treat two types of pulmonary hypertension worked well in clinical trials and should be approved, but at lower doses than those proposed by the Company, according to medical reviewers at the U.S. Food and Drug Administration. The reviewers posted their report on the agency's website in preparation for a meeting of outside medical experts who will make their own recommendation on whether the FDA should approve the drug, riociguat. If approved, the drug would be sold under the brand name Adempas. It is designed to improve the ability of patients with chronic thromboembolic pulmonary hypertension to exercise. The drug is also being developed to improve exercise ability in patients with pulmonary arterial hypertension. 

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