Actelion announced that the FDA has approved Opsumit (macitentan) tablets for the treatment of pulmonary arterial hypertension (PAH) to delay disease progression. 

Disease progression includes death, initiation of intravenous or subcutaneous prostanoids, or clinical worsening of PAH (eg, decreased 6-minute walk distance, worsened PAH symptoms, and need for additional PAH treatment). 

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Opsumit is a novel dual endothelin (ET) receptor antagonist that prevents the binding of ET-1 to both ETA and ETB receptors. Macitentan displays high affinity and sustained occupancy of the ET receptors in human pulmonary arterial smooth muscle cells.

The safety and effectiveness of Opsumit were established in a long-term Phase 3 trial called SERAPHIN, where 742 patients were randomized to take Opsumit or placebo. The average treatment duration was about two years. 

The study showed Opsumit was effective in delaying disease progression, a finding that included a decline in exercise ability, worsening symptoms of PAH or need for additional PAH medication.

Due to its Boxed Warning regarding potential fetal harm, female patients can receive the drug only through the Opsumit Risk Evaluation and Mitigation Strategy (REMS) Program. 

Opsumit will be available in 10mg dosage strength tablets in 15-count blisters and 30-count bottles in November 2013.

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