Press release
United Therapeutics Announces the Publication of Tyvaso DPI™ BREEZE Clinical and Long-term Data in the Journal Pulmonary Circulation
In subjects with PAH, transition from Tyvaso® to Tyvaso DPI™ demonstrated safety and tolerability with significant improvements in six-minute walk distance,
About this update from United Therapeutics Corporation
[{"type":"text","content":"\nIn subjects with PAH, transition from Tyvaso® to Tyvaso DPI™ demonstrated safety and tolerability with significant improvements in six-minute walk distance, device preference and satisfaction, and patient reported outcomes\n\nTyvaso DPI safety confirmed through 51 weeks of optional extension phase data with no study drug-related serious adverse events\n\nFDA action on the New Drug Application for Tyvaso DPI is expected by May 2022\n\n SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--\nUnited Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced the publication of additional clinical and long-term safety data from the BREEZE study evaluating Tyvaso DPI™ (treprostinil) in patients with pulmonary arterial hypertension (PAH) in the journal Pulmonary Circulation.\n\nThe publication evaluated the BREEZE study and its ongoing optional extension phase (OEP), and concluded:\n\n\nTyvaso DPI’s delivery device, along with the clinical results from BREEZE, may facilitate the introduction of inhaled treprostinil earlier in the clinical course of PAH for appropriate patients;\n\n\n\nDoses of Tyvaso DPI above the current recommended dose of nebulized Tyvaso (9-12 breaths four times daily) were well tolerated, potentially allowing for titration to higher dose levels without resulting in prolonged treatment sessions;\n\n\n\nA simplified dosing regimen could potentially increase patient compliance; and\n\n\n\nTyvaso DPI has a pharmacokinetic (PK) profile comparable to nebulized Tyvaso, such that patients will not have to use more drug than nebulized Tyvaso to get the same treprostinil blood concentration or treatment effect.\n\n\nTyvaso DPI is a next-generation dry powder formulation of Tyvaso, which is currently undergoing review by the U.S. Food and Drug Administration (FDA). If approved, Tyvaso DPI is expected to provide a more convenient method of administration as compared with traditional nebulized Tyvaso therapy.\n\n“If approved, I believe Tyvaso DPI could represent a very exciting addition to the treatment paradigm for the PAH population,” said Leslie Spikes, M.D., Associate Professor of Pulmonary and Critical Care Medicine at the University of Kansas Medical Center. “The ease of use, portability, and ability to titrate the dose with Tyvaso DPI should have a beneficial impact on patient...