Bayer HealthCare announced that the FDA has granted Orphan Drug Designation to riociguat, proposed trade name Adempas, for the treatment of pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH). Riociguat is an investigational oral soluble guanylate cyclase (sGC) stimulator that stimulates sGC independent of nitric oxide and increases the sensitivity of sGC to nitric oxide.

RELATED: Cardiovascular Disease Resource Center

A New Drug Application (NDA) submitted in February 2013 was for two indications, treatment of PAH (WHO Group 1) to improve exercise capacity, improve WHO functional class and delay clinical worsening; and for the treatment of persistent/recurrent CTEPH (WHO Group 4) after surgical treatment or inoperable CTEPH to improve exercise capacity and WHO functional class.

If approved by the FDA, riociguat would be the first medication in a new class of drugs.


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