United Therapeutics (UTHR), MannKind (MNKD) Announces FDA Acceptance of Tyvaso DPI NDA For Priority Review

United Therapeutics Corporation (Nasdaq: UTHR) today announced that the U.S. Food and Drug Administration (FDA) accepted for priority review the New Drug Application (NDA) for Tyvaso DPI™ (inhaled treprostinil) for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). United Therapeutics expects the agency's review to be complete in October 2021. FDA also indicated that they have not identified any potential review issues at this time.

Tyvaso DPI is a next-generation dry powder formulation of Tyvaso. If approved, Tyvaso DPI is expected to provide a more convenient method of administration as compared with traditional nebulized Tyvaso therapy.

"The acceptance of the Tyvaso DPI NDA for review represents an important regulatory step toward offering this meaningful new product to both PAH and PH-ILD patients," said Martine Rothblatt, Ph.D., Chairperson and Chief Executive Officer of United Therapeutics. "If approved, Tyvaso DPI will represent yet another path to help us achieve our goal of serving 25,000 patients by the end of 2025."

The NDA includes data from the BREEZE study that demonstrated safety and tolerability of Tyvaso DPI in patients with PAH transitioning from Tyvaso® (treprostinil) Inhalation Solution. A separate study in healthy volunteers demonstrated comparable treprostinil exposure between Tyvaso DPI and Tyvaso Inhalation Solution.

In its communications with United Therapeutics, the FDA indicated that approval of the NDA will be subject to an inspection of the Tyvaso DPI manufacturing facility operated by MannKind Corporation; FDA and MannKind have jointly targeted the third quarter of 2021 to complete the inspection.

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