U.S./EU Filings Position Bayer Compound As First Approval For CTEPH
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Bayer has filed riociguat, a first-in-class oral soluble guanylate cyclase stimulator, in the U.S. and Europe for approval in both pulmonary arterial hypertension and a related condition, persistent/recurrent chronic thromboembolic pulmonary hypertension. The compound stands to become the first drug therapy approved for CTEPH.