Bayer HealthCare announced that the FDA has approved Adempas (riociguat) tablets for the treatment of adults with persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH) (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 (PAH) (WHO Group 1) to improve exercise capacity, improve WHO functional class, and delay clinical worsening.
Adempas is the first and only approved drug for persistent/recurrent CTEPH after surgical treatment or inoperable CTEPH. It is also the only approved oral therapy in PAH as monotherapy or in combination with endothelin receptor antagonists or prostanoids.
Adempas is a stimulator of soluble guanylate cyclase (sGC), an enzyme in the cardiopulmonary system and the receptor for nitric oxide (NO). Pulmonary hypertension is associated with endothelial dysfunction, impaired synthesis of nitric oxide (NO) and insufficient stimulation of the NO-sGC-cGMP pathway. Adempas sensitizes sGC to endogenous NO by stabilizing the NO-sGC binding. Adempas also directly stimulates sGC via a different binding site independently of NO. Adempas restores the NO-sGC-cGMP pathway and leads to increased generation of cGMP with subsequent vasodialation.
For female patients, Adempas is available only through a restricted program called the Adempas Risk Evaluation and Mitigation Strategy (REMS) Program because of the possibility of embryo-fetal toxicity.
Adempas is available in 0.5mg, 1mg, 1.5mg, 2mg, and 2.5mg strength tablets in 90-count bottles and 42-count blister packs.
For more information call (855) 4-ADEMPAS or visit Bayer.com.