FDA approves Tyvaso DPI for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease.
United Therapeutics Corporation has announced that the FDA has approved Tyvaso DPI (treprostinil) inhalation powder for the treatment of pulmonary arterial hypertension (PAH; WHO Group 1) and pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability.
Tyvaso DPI represents a new formulation and inhalation device for inhaled treprostinil and is the only dry powder inhaler approved by the FDA for use in PAH and PH-ILD.
FDA approval of the new drug application for Tyvaso DPI is supported by data from BREEZE, 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, transition from Tyvaso Inhalation Solution to Tyvaso DPI demonstrated safety and tolerance during the three-week treatment phase with significant improvements in six-minute walk distance, device preference and satisfaction, and patient reported outcomes. Top line data from BREEZE were issued in January 2021, efficacy data were presented in September 2021, long-term open-label safety data were published in April 2022 (in Pulmonary Circulation journal , citation previously notified), and additional long-term safety and efficacy data were presented in May 2022.
“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,” said Shelley Shapiro, M.D., Ph.D. at the David Geffen UCLA School of Medicine Pulmonary Hypertension Program. “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.”
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