Selexipag approved for treatment of pulmonary arterial hypertension
The FDA announced approval of selexipag for treatment of patients with pulmonary arterial hypertension.
Selexipag (Uptravi, Actelion Pharmaceuticals) is an oral IP prostacyclin receptor antagonist that relaxes muscles in blood vessel walls to dilate the blood vessels and lower pressure in vessels that supply blood to the lungs, according to an agency press release.
In a clinical trial of 1,156 patients with pulmonary arterial hypertension (PAH), selexipag was associated with reduced hospitalization for PAH and reduced risk for progression of PAH compared with placebo, according to the release.
Selexipag had received orphan drug designation, a provision to help companies develop drugs to treat rare diseases, according to the release.
“Uptravi offers an additional treatment option for patients with [PAH],” Ellis Unger, MD, director of the Office of Drug Evaluation I in the FDA’s Center for Drug Evaluation and Research, said in the release. “The FDA supports continued efforts to provide new treatment option for rare diseases.”
Side effects associated with selexipag observed in the trial included headache, diarrhea, jaw pain, nausea, myalgia, vomiting, pain in an extremity and flushing, according to the release.Disclosure: Unger is an employee of the FDA.