United Therapeutics’ Tyvaso DPI Approved for Rare High Blood Pressure Disease

The FDA has approved United Therapeutics’ Tyvaso DPI (trepostinil) in an inhaled powder formulation  for patients with pulmonary arterial hypertension, a rare type of high blood pressure disease that affects arteries in the lungs and heart.

The approval was supported by positive results from a clinical trial that transitioned 51 participants from the inhalation solution to Tyvaso DPI. The powder formulation led to significant improvements in patients’ six-minute walk distance and reported outcomes, the company said.

The FDA approved Tyvaso inhalation solution for treatment of pulmonary arterial hypertension in April 28, 2009. The new formulation delivers “the proven efficacy of treprostinil through a small inhaler that fits in the palm of the patient’s hand,” said Michael Benkowitz, the company’s chief operating officer.