Bayer HealthCare Pharmaceuticals, a subsidiary of Bayer, has obtained the US Food and Drug Administration (FDA) approval for its Adempas (riociguat) tablets.
Adempas tablets are developed for the treatment of adults with persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH) (World Health Organization (WHO) Group 4)) after surgical treatment or inoperable CTEPH to improve exercise capacity and WHO functional class.
These tablets are also approved for 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 has demonstrated efficacy when administered alone or in combination with endothelin receptor antagonists (ERAs) or prostanoids (inhaled, oral or subcutaneous) in PAH patients.
Studies establishing the effectiveness of the soluable guanylate cyclase (sGC) stimulator included predominately patients with WHO functional class II-III and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (25%).
It is reportedly the first drug approved by the FDA for persistent/recurrent CTEPH after surgical treatment or inoperable CTEPH and is the only treatment approved in the US for use in two types of pulmonary hypertension (WHO Group 1 and 4).
Adempas is available only through the Adempas Risk Evaluation and Mitigation Strategy Program, a restricted distribution program, for all female patients.
By stabilizing the binding between nitric oxide (NO) and sGC, Adempas sensitizes sGC to endogenous NO and will also directly stimulate sGC through a different binding site independently of NO.
By restoring the NO-sGC-cGMP pathway, Adempas will increase cGMP generation with subsequent vasodialation.
The most common adverse reactions occurring more frequently on Adempas than placebo were headache, dyspepsia/gastritis, dizziness, nausea, diarrhea, hypotension, vomiting, anemia, gastroesophageal reflux disease, and constipation.