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FDA Advisors Recommend Approval of Hypertension Drug Riociguat (Adempas), But at Lower Doses

Drug treats two types of pulmonary hypertension (August 2)

According to Reuters, the FDA’s Cardiovascular and Renal Drugs Advisory Committee has recommended that the agency approve riociguat (Adempas), an experimental drug to treat two types of pulmonary hypertension, but at lower doses than those proposed by the drug’s developer (Bayer).

The reviewers’ report was issued ahead of their formal meeting on the drug, scheduled for August 6.

Riociguat was developed to improve exercise ability in patients with chronic thromboembolic pulmonary hypertension (CTEPH) or pulmonary arterial hypertension (PAH).

The advisory committee had concerns about the drug’s potential to cause bleeding and hypotension, and its effect on renal function.

Riociguat is the first-in-class of a new group of compounds, soluble guanylate cyclase (sGC) stimulators. sGC is a key enzyme in the cardiopulmonary system and the receptor for nitric oxide (NO). Both CTEPH and PAH are associated with endothelial dysfunction, leading to an imbalance in circulating levels of endogenous vasodilators and vasoconstrictors.

Sources: Reuters; August 2, 2013; and Bayer HealthCare; August 2013.

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