FDA approves inhaled treprostinil for treatment of PAH, pulmonary hypertension-ILD

United Therapeutics Corp. announced that the FDA has approved the Tyvaso dry powder inhaler for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease 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 pulmonary hypertension-associated ILD, according to a company press release.

“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,” Michael Benkowitz, president and chief operating officer of United Therapeutics, said in the release. “We look forward to launching this exciting new product, and the opportunity to introduce treprostinil to more patients with PAH and [pulmonary hypertension]-ILD.”

FDA approval was supported by data from the open-label BREEZE study, which enrolled 51 patients with PAH on a stable regimen of Tyvaso inhalation solution who were transitioned to Tyvaso DPI. In BREEZE, transitioning from Tyvaso inhalation solution to Tyvaso DPI was safe and tolerable during the 3-week treatment phase. Results also showed significant improvements in 6-minute walk distance, device preference and satisfaction, and patient-reported outcomes, according to the release.

“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 [pulmonary hypertension]-ILD,” Shelley M. Shapiro, MD, PhD, cardiologist in the pulmonary hypertension program at the David Geffen School of Medicine at UCLA, said in the release. “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 [pulmonary hypertension]-ILD, with the potential for improving the quality of life for this patient population.”