Uptravi Approved to Treat Pulmonary Arterial Hypertension
The FDA has approved selexipag tablets to treat pulmonary arterial hypertension among adults.
The FDA has approved selexipag (Uptravi) tablets as a treatment for pulmonary arterial hypertension among adults.
The decision made by the FDA was based on a long-term clinical trial that examined Uptravi’s safety and efficacy in more than 1100 patients.
The trial demonstrated that the tablets were successful in reducing hospitalization for pulmonary arterial hypertension and in reducing the risks of disease progression compared with placebo, according to the FDA.
In the trial, participants were exposed to the medication for a median of 1.4 years.
“Uptravi offers an additional treatment option for patients with pulmonary arterial hypertension,” said Ellis Unger, director of the Office of Drug Evaluation I in the FDA’s Center for Drug Evaluation and Research, in a press release. “The FDA supports continued efforts to provide new treatment options for rare diseases.”
Uptravi, which belongs to the oral IP prostacyclin receptor agonist family, is designed to treat pulmonary arterial hypertension by relaxing muscles in the walls of blood vessels to dilate them and decrease elevated pressure in the vessels supplying blood to the lungs.
Adverse effects associated with Uptravi include headache, diarrhea, nausea, and jaw pain.