FDA Reviewers Recommend Approval of Bayer AG Hypertension Drug But at Lower Doses

Published: Aug 05, 2013

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Bayer AG's experimental 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 on Tuesday 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.

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