Bayer HealthCare Pharmaceuticals, a subsidiary of Bayer, has obtained two separate orphan drug designations from the US Food and Drug Administration's (FDA) Office of Orphan Products Development for its investigational, oral medication riociguat, proposed trade name Adempas.
Riociguat is being developed by the company for the treatment of pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH), both life-threatening forms of pulmonary hypertension that cause significantly increased pressure in the pulmonary arteries.
In February 2013, the company submitted a new drug application for riociguat for two indications including the treatment of PAH ((World Health Organization (WHO) Group 1) to improve exercise capacity, improve WHO functional class and delay clinical worsening, and the treatment of persistent/recurrent CTEPH (WHO Group 4) after surgical treatment or inoperable CTEPH to improve exercise capacity and WHO functional class.
Riociguat, an investigational, oral medication, stimulates soluble guanylate cyclase (sGC) independent of nitric oxide (NO) and increases the sensitivity of sGC to NO.
If approved by the FDA, riociguat would create a new class of drugs available in the US for the treatment of pulmonary hypertension.
