United Therapeutics Corporation announced the submission of a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for Tyvaso DPI™, a novel dry powder inhalation formulation of treprostinil, for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease.
The submission includes the results of the recently-completed BREEZE clinical study evaluating the use of Tyvaso DPI in PAH patients transitioning from Tyvaso® (treprostinil) Inhalation Solution, along with additional pharmacokinetic data from a study in healthy volunteers.
“In the BREEZE and pharmacokinetic studies, Tyvaso DPI demonstrated safety, tolerability, and a comparable pharmacokinetic profile to nebulized Tyvaso Inhalation Solution,” said Leigh Peterson, Ph.D., Senior Vice President, Product Development at United Therapeutics. “If approved by the FDA, we expect Tyvaso DPI will provide an advancement in the delivery of inhaled treprostinil therapy.”
United Therapeutics has applied a priority review voucher to the NDA that could provide for an FDA decision by December 2021. The FDA must first accept the application for review and issue a formal decision date in accordance with the Prescription Drug User Fee Act.