New Drug Prevents Worsening Pulmonary Arterial Hypertension in Major Trial Win
(MedPage Today) -- Oral ralinepag is positioned for potential FDA approval following its strong results as a treatment for pulmonary arterial hypertension (PAH) in an international phase III trial. In ADVANCE OUTCOMES, ralinepag conferred a reduction...
Oral ralinepag demonstrated significant efficacy in preventing the worsening of pulmonary arterial hypertension (PAH), according to a major phase III trial. The study, ADVANCE OUTCOMES, showed that ralinepag reduced the risk of composite first clinical worsening events by half compared to placebo (18% vs 36%; HR 0.45, 95% CI 0.33-0.62).
These effects were observed as early as week 8 and persisted through over a year of follow-up. Additionally, ralinepag improved disease progression, initiation of alternative therapies, and long-term clinical responses. However, safety concerns include a higher rate of treatment discontinuations due to adverse events (19%) compared to placebo (3%).
The main results were presented at the American Thoracic Society annual meeting, and United Therapeutics plans to submit an FDA approval application based on these findings.
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