FDA Approves Riociguat for PAH and CTEPH

Shelley Wood

October 08, 2013

The US Food and Drug Administration (FDA) has approved riociguat (Adempas, Bayer) for the treatment of pulmonary arterial hypertension (PAH) and the treatment of chronic thromboembolic pulmonary hypertension (CTEPH), the manufacturer announced late Tuesday[1].

Specifically, riociguat is indicated for "the treatment of adults with persistent/recurrent chronic thromboembolic pulmonary hypertension . . . (WHO Group 4) after surgical treatment or inoperable CTEPH to improve exercise capacity and WHO functional class; and  the treatment of adults with pulmonary arterial hypertension . . . (WHO Group 1) to improve exercise capacity, improve WHO functional class and delay clinical worsening," a company press release stated.

As previously reported by heartwire , an FDA advisory committee voted unanimously this summer to recommend approval of the drug for these indications. Riociguat is a vasodilator that restores the nitric-oxide–soluble guanylate cyclase-cyclic guanosine monophosphate (NO-sGC-cGMP) pathway by directly stimulating sGC independent of NO and sensitizing sGC to low levels of NO.

Bayer had applied for a new drug application for riociguat in February 2013 seeking these two indications. Evidence for the approvals comes from the results of two randomized, double-blind, placebo-controlled, multicenter, multinational phase 3 studies of riociguat, which were published in the July 25, 2013 issue of the New England Journal of Medicine.


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