The FDA has approved Yutrepia, a dry-power formulation of treprostinil for patients with pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease to improve exercise capacity in adults.

FDA approval was based on findings from the Phase 3 INSPIRE trial, which enrolled both treprostinil-naïve patients and those transitioning from nebulized treprostinil. Yutrepria demonstrated a favorable tolerability profile, with the most common adverse events (10% or more) being cough, headache, throat irritation, and dizziness. The therapy was well tolerated regardless of prior exposure to treprostinil.

Treprostinil’s mechanism of delivery may offer practical advantages for patients with impaired inspiratory effort, including those with advanced pulmonary disease. It is indicated for patients with pulmonary arterial hypertension (PAH) predominantly in NYHA Functional Class III and for pulmonary hypertension associated with interstitial lung disease (PH-ILD) etiologies such as idiopathic interstitial pneumonia, combined pulmonary fibrosis and emphysema, and connective tissue disease-associated ILD.

Safety considerations include the potential for symptomatic hypotension due to systemic vasodilation, inhibition of platelet aggregation with associated bleeding risk, and acute bronchospasm in patients with reactive airway disease. Clinicians are advised to evaluate concomitant medications, particularly cytochrome P450 2C8 modulators, which may alter treprostinil exposure.

Legal proceedings initiated by United Therapeutics Corporation against the manufacturer (Liqiudia Technologies) regarding patent infringement remain ongoing, with a motion for a preliminary injunction to block commercialization currently pending. Liquidia is scheduled to provide an update on launch preparations via webcast on May 27, 2025.

Yutrepia represents an additional therapeutic option within the prostacyclin class for the management of PAH and PH-ILD. Full prescribing information is available at Yutrepia.com.

Source: Liquidia Technologies, Inc.