Uptravi (Selexipag) Approved for Treatment of Pulmonary Arterial Hypertension

New Drugs , News / October 7, 2016

The FDA approved Uptravi (selexipag) tablets for the treatment of adults with pulmonary arterial hypertension (PAH), a chronic, progressive and debilitating rare lung disease that can lead to death or the need for lung transplantation.

PAH is high blood pressure that occurs in the arteries connecting the heart to the lungs. It causes the right side of the heart to work harder than normal, which can lead to limitations in exercise ability and shortness of breath, among other more serious complications.

Uptravi belongs to a class of drugs called oral IP prostacyclin receptor agonists. The drug acts by relaxing muscles in the walls of blood vessels causing them to dilate thus decreasing the elevated blood pressure in the vessels supplying blood to the lungs.

Uptravi’s safety and efficacy were established in a long-term clinical trial of 1,156 participants with PAH. Uptravi was shown to be effective in reducing hospitalization for PAH and reducing the risks of disease progression compared to placebo. Participants were exposed to Uptravi in this trial for a median duration of 1.4 years.

Common side effects observed in those treated with Uptravi in the trial include headache, diarrhea, jaw pain, nausea, muscle pain (myalgia), vomiting, pain in an extremity, and flushing.

Uptravi is marketed by San Francisco-based Actelion Pharmaceuticals US, Inc.

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