FDA Review Of Bayer’s Riociguat Suggests It’s All About The Dose
This article was originally published in The Pink Sheet Daily
Executive Summary
Agency will seek Cardiovascular and Renal Drugs Advisory Committee’s views on a dosing algorithm for the novel pulmonary arterial hypertension drug; FDA clinical reviewer recommends approval but with lower starting and maximum doses than those used in the pivotal trials due to risk of drug-induced hypotension.
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