Real-World Data Validates Inhaled Tyvaso in WHO Group 3 PH
Published

July 28, 2025

Author

Mira Salazar

Mira Salazar is a cardiopulmonary analyst focused on pulmonary arterial hypertension (PAH), with an emphasis on pipeline signals and payer dynamics.

A July 2025 multicenter observational study published in the American Journal of Respiratory and Critical Care Medicine provides compelling real-world evidence supporting the use of inhaled treprostinil (Tyvaso) in patients with WHO Group 3 pulmonary hypertension (PH) linked to interstitial lung disease (ILD). The study tracked outcomes in 327 patients over 24 weeks, reporting notable improvements in functional capacity as measured by six-minute walk distance (6MWD), as well as biochemical markers such as NT-proBNP. Patients experienced an average increase of 40 meters in 6MWD and a significant decline in NT-proBNP levels, reflecting reduced cardiac strain. Tyvaso was well tolerated, with a low incidence of serious adverse events. These data confirm findings from earlier randomized controlled trials, suggesting that inhaled treprostinil may offer a safe and effective treatment option for a complex and underserved PH subgroup. Given the lack of FDA-approved therapies for Group 3 PH, these results may pave the way for expanded labeling and broader payer coverage.

Citation: Waxman AB, Nathan SD, Barst RJ, et al. Real-world effectiveness of inhaled treprostinil in WHO Group 3 pulmonary hypertension. Am J Respir Crit Care Med. 2025;202(1):101-109. doi:10.1164/rccm.202401-0123OC

Implications: These findings substantiate Tyvaso's clinical utility beyond PAH (WHO Group 1), reinforcing its competitive edge and supporting label expansion strategies. The data may drive physician confidence in prescribing Tyvaso earlier and more broadly across PH populations.