FDA Approves New Formulation of Tyvaso

FDA has approved United Therapeutics’ Tyvaso DPI (treprostinil) inhalation powder to treat patients with pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. Tyvaso DPI is a new formulation and inhalation device for inhaled treprostinil and is the only dry powder inhaler approved by the FDA for these indications.

Pulmonary arterial hypertension is life-threatening high blood pressure in the arteries of the lungs, affecting the ability of the heart and lungs to work properly. It affects an estimated 45,000 patients in the United States. Interstitial lung disease is a group of conditions in which marked scarring occurs within the lungs. It is often complicated by pulmonary hypertension, which is estimated to affect at least 15% of patients with early-stage ILD.

Tyvaso Inhalation Solution and Tyvaso DPI are the only therapies approved by the FDA to treat pulmonary hypertension associated with interstitial lung disease.

“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,” Shelley Shapiro, M.D., Ph.D., at the David Geffen UCLA School of Medicine Pulmonary Hypertension Program, said in a press release.

The approval for Tyvaso DPI is supported by data from BREEZE, an open-label study of 51 patients with pulmonary arterial hypertension taking Tyvaso who were transitioned to Tyvaso DPI. The new formulation demonstrated safety and tolerance during the three-week treatment phase with significant improvements in six-minute

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.