The Food and Drug Administration (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 is a drug-device combination therapy that consists of a dry powder formulation of treprostinil and a small, portable, dry powder inhaler. The approval was supported by data from the open-label phase 1 BREEZE study (ClinicalTrials.gov Identifier: NCT03950739), which evaluated the safety and tolerability of Tyvaso DPI in 51 adult patients with PAH on a stable regimen of Tyvaso inhalation solution.
Findings demonstrated that the transition from Tyvaso inhalation solution to Tyvaso DPI was safe and well tolerated (primary endpoint). Significant improvements in 6-minute walk distance, device preference and satisfaction, and patient reported outcomes (all secondary endpoints) were also reported.
In a separate pharmacokinetics study, results showed comparable systemic treprostinil exposure for each corresponding Tyvaso DPI and Tyvaso inhalation solution dose level.
“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,” said Michael Benkowitz, President and Chief Operating Officer of United Therapeutics.
Tyvaso DPI is available as 16mcg, 32mcg, 48mcg, or 64mcg of treprostinil in single-dose cartridges; 4 cartridges are contained in a single cavity of a blister strip. A card contains 7 blister strips separated by perforations for a total of 28 cartridges of each labeled strength in the Titration and Maintenance Kits.
The Tyvaso DPI Inhaler can be used for up to 7 days from the date of first use, after which it must be discarded and replaced with a new inhaler.
Tyvaso DPI is expected to be available in June 2022.
- United Therapeutics announces FDA approval of Tyvaso DPI™. News release. May 24, 2022. https://www.businesswire.com/news/home/20220524005338/en/United-Therapeutics-Announces-FDA-Approval-of-Tyvaso-DPI%E2%84%A2
- Tyvaso DPI. Package insert. United Therapeutics; 2022. Accessed May 25, 2022. https://www.tyvasohcp.com/pdf/TYVASO-DPI-PI.pdf