Press release
United Therapeutics Presents Tyvaso DPI™ BREEZE Clinical Data At The European Respiratory Society International Congress 2021
In subjects with PAH, transition from Tyvaso® to Tyvaso DPI™ demonstrated safety and tolerance with significant improvements in six-minute walk distance,
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[{"type":"text","content":"In subjects with PAH, transition from Tyvaso® to Tyvaso DPI™ demonstrated safety and tolerance with significant improvements in six-minute walk distance, device preference and satisfaction, and patient reported outcomes\n FDA action on New Drug Application for Tyvaso DPI expected in October 2021\n\n\nSILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Sept. 7, 2021 /PRNewswire/ -- United Therapeutics Corporation (Nasdaq: UTHR) today presented new clinical data from the BREEZE study evaluating Tyvaso DPI™ (treprostinil) in patients with pulmonary arterial hypertension (PAH) at the European Respiratory Society (ERS) International Congress 2021. \nTyvaso DPI is a next-generation dry powder formulation of Tyvaso® (treprostinil) Inhalation Solution (Tyvaso), which is currently under 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\"The transition from nebulized Tyvaso to Tyvaso DPI demonstrated safety and tolerance with significant improvements in six-minute walk distance and other key factors,\" said Leslie Spikes, M.D., Associate Professor of Pulmonary and Critical Care Medicine at the University of Kansas Medical Center. \"The results of the study, even when taken into the context of the unblinded study design, indicate that Tyvaso DPI is a convenient, tolerable treprostinil formulation that could increase prostacyclin accessibility, with the potential to improve patient outcomes.\"\n\"At United Therapeutics, we continue to strive to make treprostinil therapy more accessible for our pulmonary hypertension patients,\" said Peter Smith, PharmD, Vice President, Product Development at United Therapeutics. \"As such, we are thrilled to share the BREEZE study data demonstrating the safety and tolerability of treprostinil administered as Tyvaso DPI, which, if approved by the FDA, could represent a more convenient formulation of inhaled treprostinil.\" \nThe BREEZE studyThe BREEZE study enrolled 51 subjects on a stable regimen of Tyvaso who were transitioned to Tyvaso DPI at a corresponding treprostinil dose. The primary objective of the study was to evaluate the safety and tolerability of Tyvaso DPI during a three-week treatment phase in PAH patients previously treated with Tyvaso Inha...