FDA Accepts Application for Ralinepag to Treat Pulmonary Arterial Hypertension

United Therapeutics Corporation announced the FDA has accepted its New Drug Application (NDA) for ralinepag, an investigational drug for pulmonary arterial hypertension (PAH). If approved, ralinepag could be the first once-daily oral prostacyclin for this life-threatening disease. The NDA is supported by Phase 3 ADVANCE OUTCOMES study results, demonstrating a 55% reduction in clinical worsening risk. The FDA's PDUFA target action date is June 24, 2027.