United Therapeutics submits Tyvaso DPI NDA to FDA for pulmonary arterial hypertension and for pulmonary hypertension /interstitial lung disease.

There are approximately 45,000 treated PAH patients in the U.S. and United Therapeutics estimates at least 30,000 treatable PH-ILD patients in the U.S. 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. 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.. About Tyvaso DPI: Tyvaso DPI is an investigational drug-device combination therapy comprised of a dry powder formulation of treprostinil and a small, portable, dry powder inhaler. If approved, Tyvaso DPI is expected to provide a more convenient method of administration compared with traditional nebulized Tyvaso therapy. United Therapeutics is developing Tyvaso DPI under a collaboration and license agreement with MannKind Corporation (Nasdaq: MNKD). Tyvaso DPI incorporates the dry powder formulation technology and Dreamboat inhalation device technology used in MannKind's Afrezza (insulin human) Inhalation Powder product, which was approved by the FDA in 2014. United Therapeutics and MannKind are also developing BluHale, a Bluetooth-connected accessory for the Tyvaso DPI inhaler with a companion mobile application intended to help the patient track information about inhaler use.