The FDA approved selexipag on Dec. 21 to treat adults with pulmonary arterial hypertension (PAH), delay disease progression and reduce the risk of hospitalization for PAH.
The medication (Uptravi, Actelion Pharmaceuticals), an oral IP prostacyclin receptor antagonist, was granted orphan status because it is intended for a rare disease or condition. Patients with PAH have high blood pressure in the arteries that connect the heart to the lungs.
The drug is expected to be available in the U.S. in early January 2016, according to Actelion.
The approval was based on results of a long-term, placebo-controlled trial that included 1,156 patients with PAH with World Health Organization Class II or III symptoms. The median duration of exposure to selexipag was 1.4 years.
In the study, patients who received selexipag had a reduced risk of disease progression and a decline in hospitalizations for PAH compared with a placebo group. Common side effects associated with selexipag included headache, diarrhea, jaw pain, nausea, myalgia, vomiting, pain in an extremity and flushing.