Tyvaso DPI represents a new formulation and inhalation device for inhaled treprostinil and is the first and only dry powder inhaler approved by the FDA for use in PAH and PH-ILD. The manufacturer indicated that commercial launch initiatives are underway and that patient availability is expected in June 2022.
FDA approval of the new drug application for Tyvaso DPI is supported by data from BREEZE. BREEZE is an open-label study of 51 PAH patients on a stable regimen of Tyvaso inhalation solution who were transitioned to Tyvaso DPI. In subjects with PAH, the transition from Tyvaso inhalation solution to Tyvaso DPI demonstrated safety and tolerance during the 3-week treatment phase, with significant improvements in 6-minute walk distance, device preference and satisfaction, and patient-reported outcomes.
Top-line data from the BREEZE study were issued in January 2021, efficacy data were presented in September 2021, long-term open-label safety data were published in April 2022, and additional long-term safety and efficacy data were presented in May 2022.
In the press release, Michael Benkowitz, President and COO of United Therapeutics, stated, "Tyvaso DPI is one of the easiest ways for patients to administer a prostacyclin, delivering the proven efficacy of treprostinil through a small inhaler that fits in the palm of the patient's hand. We look forward to launching this exciting new product, and the opportunity to introduce treprostinil to more patients with PAH and PH-ILD."
Additionally, Shelley Shapiro, MD, PhD, at the David Geffen UCLA School of Medicine Pulmonary Hypertension Program in Los Angeles, California, stated, "Prostacyclin-based therapies are effective in treating PAH, and recent data from the INCREASE study has shown that inhaled treprostinil is an effective treatment for PH-ILD. The convenience and portability of Tyvaso DPI may make it an important new option for patients with WHO Group 1 PAH and with WHO Group 3 PH-ILD, with the potential for improving the quality of life for this patient population."
« Click here to return to Cardiology Update.