United Therapeutics NDA for Tyvaso DPI to Get Priority Review
June 16 2021 - 6:30AM
Dow Jones News
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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