FDA Clears Selexipag for Pulmonary Arterial Hypertension

Megan Brooks


December 22, 2015

The US Food and Drug Administration (FDA) has approved the orphan drug selexipag (Uptravi, Actelion) for treatment of adults with pulmonary arterial hypertension (PAH), a chronic and progressive rare lung disease that can lead to premature death or the need for transplantation.

Selexipag is an oral IP prostacyclin receptor agonist that relaxes muscles in the walls of blood vessels to dilate blood vessels and decrease the elevated pressure in the vessels supplying blood to the lungs.

The safety and efficacy of selexipag were demonstrated in a clinical trial of 1156 adults with PAH who were treated for a median of 1.4 years. The drug proved effective in reducing hospitalization for PAH and the risk for disease progression compared with placebo, the FDA said.

The benefit of selexipag was "consistent across pre-specified patient subgroups such as disease etiology, functional class and baseline PAH therapy, including patients already receiving combination therapy with an endothelin receptor antagonist and a PDE-5 inhibitor," the company said in a news release.

Common adverse effects seen in the trial included headache, diarrhea, jaw pain, nausea, myalgia, vomiting, extremity pain, and flushing.

Selexipag "offers an additional treatment option" for patients with PAH," Ellis Unger, MD, from the FDA's Center for Drug Evaluation and Research, said in a statement.

Actelion Chief Executive Officer Jean-Paul Clozel said selexipag will "significantly expand the options to delay disease progression after initiation of therapy with a baseline treatment like Opsumit (macitentan), and well ahead of Veletri (epoprostenol) for the late disease stage."

The company expects selexipag to launch in the United States in early January.

Selexipag is currently under review in Europe, Australia, Canada, New Zealand, South Korea, Switzerland, and Taiwan, the company said.


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