According to Liquidia, the FDA has granted Fast Track designation to the company’s Yutrepia inhaled dry powder treprostinil for the treatment of Raynaud’s phenomenon associated with systemic sclerosis (SSc-RP.). Yutrepia is currently approved in the US for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).
Liquidia says that it is preparing to initiate the Phase 2a RE-WARM trial of Yutrepia in patients with systemic sclerosis who experience Raynaud’s phenomenon, with the study expected to conclude in February 2027. The company says that its estimate of the potential patient population for the indication in the US is approximately 30,000.
Liquidia Chief Medical Officer Rajeev Saggar commented, “Fast Track designation reflects the seriousness of this condition and the need for new options. No therapy is currently approved by the FDA specifically for SSc-RP. We are encouraged by the opportunity to evaluate whether Yutrepia can reduce the complications of moderate to severe Raynaud’s that most affect patients’ quality of life, and we are committed to advancing this program with urgency, starting with the RE-WARM study later this year.”
Read the Liquidia press release
