SILVER SPRING
Ralinepag NDA accepted for pulmonary arterial hypertension
- Sponsor
- United Therapeutics Corporation $UTHR
- Drug
- ralinepag
- Indication
- pulmonary arterial hypertension (PAH)
FDA accepted United Therapeutics' NDA for ralinepag, an oral prostacyclin (IP) receptor agonist for pulmonary arterial hypertension. PDUFA target action date is June 24, 2027.
What this means
Pulmonary arterial hypertension (PAH) is a progressive disease where narrowed lung arteries strain the heart. United Therapeutics's ralinepag is a once-daily oral pill that activates the same prostacyclin pathway as older PAH drugs, most of which require complex dosing or infusion. FDA acceptance starts the formal review; the target action date is June 24, 2027. If approved, ralinepag would be the first once-daily oral prostacyclin agent for PAH. In the Phase 3 ADVANCE OUTCOMES trial, it reduced the risk of clinical worsening by 55% compared with placebo.