United Therapeutics NDA for Tyvaso DPI to Get Priority Review

By Chris Wack

United Therapeutics Corp. said the U.S. Food and Drug Administration has accepted for priority review the New Drug Application for Tyvaso DPI inhaled treprostinil for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease.

The company said it expects the agency's review to be complete in October. The FDA also indicated that it hasn't 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 compared with traditional nebulized Tyvaso therapy.

The NDA includes data from a 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 Corp. FDA and MannKind have jointly targeted the third quarter of 2021 to complete the inspection.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

June 16, 2021 06:24 ET (10:24 GMT)

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