The US Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee has recommended approval of Bayer’s oral soluble guanylate cyclase (sGC) stimulator, riociguat, in two forms of pulmonary hypertension.
The committee unanimously approved that the medicine should be used in the treatment of pulmonary arterial hypertension (PAH) of WHO Group 1 as well as chronic thromboembolic pulmonary hypertension (CTEPH) of WHO Group 4.
Bayer submitted a new drug application in February 2013, for riociguat in two indications.
The drug application for riociguat was supported by data from the PATENT-1 trial in PAH and the CHEST-1 trial in CTEPH, which assessed the efficacy and safety of oral riociguat in the treatment of CTEPH and PAH respectively.
Bayer healthcare executive committee and global development head Dr Kemal Malik said the committee's recommendation confirms the positive benefit-risk profile of this new first-in-class therapeutic option.
Riociguat is the first member of a novel class of compounds, the stimulators of soluble guanylate cyclase (sGC).