October 09 ,2013 | By Márcio Barra
Adempas (riociguat), a first-in-class oral soluble guanylate cyclase stimulator from Bayer, has been approved today by the FDA for the treatment of Pulmonary Artery Hypertension (PAH) and as the first approved treatment for Chronic ThromboEmbolic Pulmonary Hypertension (CTEPH).
“Adempas is the first in its drug class approved to treat pulmonary hypertension and the first drug of any class to be shown to be effective for patients with CTEPH,” said Norman Stockbridge, director of the Division of Cardiovascular and Renal Drug Products in the FDA’s Center for Drug Evaluation and Research.
The drug, reviewed under the FDA’s 6 months priority review program, is noteworthy as it is the first approved treatment for chronic thromboembolic pulmonary hypertension, a more severe subset of pulmonary hypertension characterized by blockage of large pulmonary arteries by acute and recurrent pulmonary emboli, and organisation of these blood clots, which affects between…
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