Actelion Gets PAH Exercise Claim

Long-time readers of Pharm Aid know of my interest in PAH – pulmonary arterial hypertension.  Today, there was a new development as the FDA approved Actelion Pharmaceutical’s sNDA application for Veletri (epoprostenol) for an “improved exercise capacity” claim.

"This is one example of our continued and long-term commitment to patients with pulmonary arterial hypertension," said Shal Jacobovitz, President of Actelion Pharmaceuticals US, Inc. "Second generation VELETRI provides patients and their caregivers a treatment option that allows patients to have more flexibility in their daily lives."

It’s not a NME for Actelion, but will provide added flexibility in the clinical routine and benefit patients who really struggle with the disease.

Source:  Actelion press release