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
FDA action on New Drug Application for Tyvaso DPI expected in October 2021
SILVER 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.
Tyvaso 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.
"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."
"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."
The 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 Inhalation Solution. Top line data showing the BREEZE study met its primary objective were released in January 2021.
Secondary objectives of the study included changes in six-minute walk distance (6MWD), device preference and satisfaction as evaluated through the Preference Questionnaire for Inhaled Treprostinil Devices (PQ-ITD), and patient reported PAH symptoms and impact (PAH-SYMPACT®).
Primary safety and tolerability objective. Transition from Tyvaso to Tyvaso DPI demonstrated safety and tolerance. Forty-nine out of 51 patients (96%) completed the three-week treatment phase, while two subjects discontinued due to treatment-related adverse events during the treatment phase. There were no study drug-related serious adverse events. Most adverse events experienced during the study were mild to moderate in severity and occurred at severities and frequencies consistent with those seen in other inhaled treprostinil studies in patients with PAH. Please see Important Safety Information about Tyvaso at the end of this press release.
Secondary objectives. Three weeks after switching from Tyvaso to Tyvaso DPI, patients in the BREEZE study demonstrated:
- Significant improvements in 6MWD compared to baseline. Improvements of 11.5 meters (p=0.0217) in 6MWD compared to baseline were observed through the three-week treatment phase.
- Significant improvements in overall satisfaction with the Tyvaso DPI inhaler. Using the PQ-ITD, significant improvements (p