RESEARCH TRIANGLE PARK — United Therapeutics has applied for a priority review voucher and submitted a new drug application to the United States Food and Drug Administration, the company announced this week. The drug, Tyvaso DPI™, is a novel dry powder inhalation formulation of treprostinil, and, if approved, will be used to treat pulmonary arterial hypertension (PAH).
The company estimates there are about 30,000 treatable patients in the United States, according to a statement.
“Since our founding, we’ve worked hard to ensure our patients have ample choices to deliver treprostinil in various ways to suit their individual needs,” said Gil Golden, M.D., Ph.D., Chief Medical Officer of United Therapeutics. “If approved, Tyvaso DPI™ will enable patients to go about their day with just a small breath-actuated, dry powder inhaler that easily fits inside a pocket and requires no batteries or external power source to operate.”
The FDA must first accept the application for review, later issuing a formal decision date, in accordance with the prescription drug user fee act. The drug therapy is not currently approved for use in any country, and the company is developing the drug under a collaboration and license agreement with MannKind Corporation.
