United Therapeutics Announces BREEZE Study of Investigational Tyvaso DPI™ Meets Primary Objective
Study demonstrated safety and tolerability of Tyvaso DPI™ in patients with PAH transitioning from Tyvaso® Inhalation Solution
A separate study in healthy volunteers demonstrated comparable treprostinil exposure between Tyvaso DPI and Tyvaso Inhalation Solution
Tyvaso DPI NDA filing anticipated in April 2021 with priority review
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SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Jan. 28, 2021 /PRNewswire/ United Therapeutics Corporation (Nasdaq: UTHR) announced today that that the BREEZE study of Tyvaso DPI (inhaled treprostinil) met its primary objective of demonstrating safety and tolerability in patients with pulmonary arterial hypertension (PAH) transitioning from Tyvaso (treprostinil) Inhalation Solution. In addition, a pharmacokinetic (PK) study in healthy volunteers demonstrated comparable treprostinil exposure
United Therapeutics Announces Agreement To Acquire Priority Review Voucher
Voucher expected to be applied to the forthcoming NDA for Tyvaso DPI™
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SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Dec. 28, 2020 /PRNewswire/ United Therapeutics Corporation (Nasdaq: UTHR) announced today an agreement to acquire a Rare Pediatric Disease Priority Review Voucher (PRV), which it plans to use with a forthcoming New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA). The PRV entitles the holder to designate an NDA for priority review and provides for an expedited eight-month review, instead of the standard twelve-month review period. Following the close of the transaction, United Therapeutics intends to apply the PRV to its NDA for Tyvaso DPI, expected in the first half of 2021.