FDA reviewer: Bayer's riociguat 'approvable' at lower dose
This article was originally published in Scrip
Executive Summary
Bayer Healthcare's riociguat is approvable as a treatment for chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary arterial hypertension (PAH) as long as the drug is marketed at a dose lower than the one proposed by the company, an FDA reviewer said.