THE U.S. Food and Drug Administration has approved a novel inhaled formulation of treprostinil for adults with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD), adding a new option for improving exercise ability in these patient populations.
This approval marks the first and only prostacyclin analog delivered as a dry-powder inhalation formulation, enabled by proprietary particle-engineering technology designed for consistent deep-lung delivery. The formulation’s inhaler device is notable for requiring minimal inspiratory effort, making it especially suitable for patients with compromised lung function.
Findings from the pivotal Phase 3 INSPIRE trial supported the FDA’s decision. The trial evaluated both treatment-naïve patients and those transitioning from nebulized treprostinil. The inhaled powder demonstrated favorable safety and tolerability across both cohorts. The ease of titration and overall durability of the therapy were also highlighted.
Pulmonary hypertension expert Nicholas Hill, Professor of Medicine at Tufts University and the trial’s principal investigator, emphasized the value of this advancement. “I am so pleased that patients with PAH and PH-ILD now have this newly introduced option for inhaled treprostinil. Having treated patients for more than six years in Liquidia’s INSPIRE and extension studies, I am confident in the safety, tolerability and dosing that YUTREPIA offers,” he stated. He also noted that the low-effort inhaler could help more patients start and maintain treatment, particularly those with limited inspiratory ability.
According to the Pulmonary Hypertension Association, more than 105,000 patients in the U.S. are affected by PAH and PH-ILD, underlining the significance of therapeutic innovations that can enhance quality of life.
Despite this regulatory success, the product’s commercial launch may face legal hurdles. A patent dispute is currently pending in federal court following a complaint from United Therapeutics Corporation, which seeks to block the market entry of this new therapy.
Reference:
Liquidia Corporation. U.S. FDA Approves Liquidia’s YUTREPIA™ (treprostinil) Inhalation Powder for Patients with Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD). 23 May 2025. https://www.liquidia.com/news-releases/news-release-details/us-fda-approves-liquidias-yutrepiatm-treprostinil-inhalation. Accessed 27 May 2025.
