FDA approves new pulmonary arterial hypertension drug

The Food and Drug Administration (FDA) granted approval Monday for Uptravi, a new oral IP prostacyclin receptor agonist medication to treat adults with pulmonary arterial hypertension (PAH).

PAH is a rare, chronic lung disease that starts when arterial high blood pressure causes the right side of the heart to work harder than normal. PAH is a progressive disease that can cause shortness of breath, limit exercise capabilities as well as cause other more serious complications, such as the need for a transplant or death.

Uptravi is a designated orphan drug that works by relaxing the muscles in the walls of blood vessels that in turn cause the blood vessels to dilate. This effect causes a decrease in the elevated pressure of the vessels that supply blood to the lungs. Some common side effects detected in those treated with Uptravi include headache, diarrhea, jaw pain, nausea, muscle pain, vomiting and flushing.

“Uptravi offers an additional treatment option for patients with pulmonary arterial hypertension,” Director of the Office of Drug Evaluation I in the FDA’s Center for Drug Evaluation and Research Ellis Unger, MD, said. “The FDA supports continued efforts to provide new treatment options for rare diseases.”

Marketed by San Francisco-based Actelion Pharmaceuticals US Inc., Uptravi’s safety was established in a long-term clinical trial consisting of 1,156 participants with PAH.