Lung Drug Gets FDA Approval

The US Food and Drug Administration approved selexipag (Uptravi/Actelion Pharmaceuticals US) for treatment of pulmonary arterial hypertension (PAH) in adults.

The condition is a rare lung disease that can lead to the need for transplantation and can be fatal.

PAH is high blood pressure that occurs in the arteries connecting the heart to the lungs. It cause the right side of the heart to pump harder than normal which can lead to limitations on patients' ability to exercise, shortness of breath, and other symptoms.

The drug belongs to a class called oral IP prostacyclin receptor agonists, the FDA said in announcing the approval. "The drug acts by relaxing muscles in the walls of blood vessels to dilate blood vessels and decrease the elevated pressure in the vessels supplying blood to the lungs."

Side effects in a long-term trial involving 1,156 participants included headache, diarrhea, jaw pain, nausea, myalgia, vomiting, extremity pain, and flushing.

It has been given orphan drug designation.