United Therapeutics Receives Orphan Drug Designation for Tyvaso

The FDA has handed United Therapeutics an Orphan Drug designation for Tyvaso (treprostinil) inhalation solution, a prostacyclin vasodilator, for the treatment of idiopathic pulmonary fibrosis (IPF), a serious lung disease.

IPF is a chronic and progressive form of pneumonia that typically occurs in patients older than 50, and it isn’t currently known what causes it. The infection frequently causes progressive fibrosis, lung scarring and a radiological pattern known as usual interstitial pneumonia.

The company said that the agency recently cleared the drug for a phase 3 trial, and it expects to start enrolling participants next year.