Bayer’s Adempas Overcomes FDA Dosing Concerns To Win Approval
This article was originally published in The Pink Sheet Daily
Executive Summary
Riociguat becomes the first therapy indicated for chronic thromboembolic pulmonary hypertension in the U.S. Labeling includes Bayer’s recommended starting and maximum doses but provides the option for a lower starting dose in patients who may not tolerate the hypotensive effects, a concern for agency reviewers.
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