Selexipag has been approved to treat pulmonary arterial hypertension, the Food and Drug Administration announced on Dec. 21 in a statement.
“The FDA supports continued efforts to provide new treatment options for rare diseases,” Dr. Ellis Unger, director of the Office of Drug Evaluation I in the FDA’s Center for Drug Evaluation and Research, said in the statement. Selexipag (Uptravi) was granted orphan drug designation, which provides incentives such as tax credits, user fee waivers, and eligibility for exclusivity to assist and encourage the development of drugs for rare diseases.
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Selexipag is an oral IP prostacyclin receptor agonist that dilates blood vessels, decreasing elevated pressure in pulmonary vessels.
In a trial of 1,156 patients with PAH, selexipag use for a median duration of 1.4 years was associated with fewer hospitalizations for PAH and a lower risk of disease progression, compared with placebo.
Common side effects observed in those treated with selexipag in the trial include headache, diarrhea, jaw pain, nausea, myalgia, vomiting, pain in an extremity, and flushing.
Uptravi is marketed by San Francisco–based Actelion Pharmaceuticals US.
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