Selexipag

(Uptravi®)

Uptravi®

Drug updated on 10/31/2024

Dosage FormTablet (oral; 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1000 mcg, 1200 mcg, 1400 mcg, 1600 mcg); Injection (Intravenous; 1800 mcg)
Drug ClassProstacyclin receptor agonists
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression and reduce the risk of hospitalization for PAH.

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Summary
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  • This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
  • Functional Class and Six-Minute Walk Distance (6MWD) Improvement: Selexipag improved WHO (World Health Organization) functional class (FC) with an odds ratio of 0.564 (95% CI (confidence interval): 0.457-0.697) and significantly increased 6MWD, with a mean difference of 24.20 m (95% CI: 10.74-37.67), particularly after more than 6 months of treatment (MD (mean difference): 40.87 m, 95% CI: 10.97-70.77).
  • Clinical Worsening Reduction and Pulmonary Vascular Resistance (PVR): Selexipag reduced the risk of clinical worsening by 39% when compared to placebo and significantly improved PVR in patients.
  • Cardiac Index (CI) and N-terminal Prohormone BNP (NT-proBNP (B-type natriuretic peptide)) Levels: Selexipag led to a mean improvement in CI (MD: 0.47 L/min/m², 95% CI: 0.17-0.77), with notable improvements even at moderate dosages and within 6 months of treatment; it also improved NT-proBNP levels significantly over extended treatment durations (SMD: -0.61, 95% CI: -1.17 to -0.05).
  • There is no safety information available in the reviewed studies.
  • The reviewed studies included patients with connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH), with subgroups of systemic sclerosis (59%), systemic lupus erythematosus (20%), and other connective tissue diseases (21%); maintained doses of selexipag (low, medium, high) showed favorable effects on six-minute walk distance (6MWD), WHO functional class, NT-proBNP, and cardiac index, particularly with treatment exceeding six months.

Product Monograph / Prescribing Information

Document TitleYearSource
Uptravi (selexipag) Prescribing Information.2022Janssen Biotech, Inc., Titusville, NJ

Systematic Reviews / Meta-Analyses