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UPTRAVI® (selexipag) is an oral selective prostacyclin (IP) receptor agonist that is distinct from prostacyclin and its analogues, with a higher selectivity for the IP receptor vs other prostanoid receptors. Stimulation of the IP receptor by UPTRAVI® and its active metabolite leads to vasodilatory as well as anti-proliferative and anti-fibrotic effects.[1]

UPTRAVI® was approved by the European Medicines Agency (EMA) in 2016 for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients with World Health Organization (WHO) functional class (FC) II–III. UPTRAVI® can be used as either a combination therapy in patients insufficiently controlled with an endothelin receptor antagonist (ERA) and/or a phosphodiesterase type-5 inhibitor (PDE-5i), or as monotherapy in patients who cannot tolerate these medications. Efficacy has been shown in a PAH population including idiopathic and heritable PAH, PAH associated with connective tissue disorders, and PAH associated with corrected simple congenital heart disease.[1]

UPTRAVI® in PAH: From pre-clinical development to real-world experience
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Based on pre-clinical, clinical and real-world experience[1][2][3][4][5][6][7][8][9][10]

*As measured by a composite primary morbidity-mortality endpoint. Results were driven by a decrease in disease progression and hospitalisations due to PAH; they do not apply to mortality on its own.[5]

Explore the efficacy of UPTRAVI®

The efficacy and safety of UPTRAVI® were investigated in GRIPHON, the largest outcomes trial conducted in pulmonary arterial hypertension (PAH) to date.[5][6] Explore the trial data to find out how UPTRAVI® can make a difference for your patients with PAH.

The value of early initiation

Proactively initiating UPTRAVI® early can give your patients more time.[13]

Improvement in patient risk status

UPTRAVI® can help your patients with PAH achieve and maintain a low-risk status.[9][14]

The benefits of triple combination

Adding UPTRAVI® in triple combination therapy provides benefits for your patients with PAH.[15]

Beneficial in a broad range of patients

UPTRAVI® can provide beneficial long-term outcomes for a broad range of patients with PAH.[5]

Give your patients with PAH time, add UPTRAVI®

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Targeting the prostacyclin pathway with UPTRAVI® can improve long-term outcomes in PAH

Primary endpoint: 40% reduction in the risk of a morbidity-mortality event vs placebo in the GRIPHON trial.*[5]

*Composite primary endpoint. Results do not apply to mortality on its own (HR 0.60; 99% CI: 0.46–0.78; p<0.001).[5]

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Adding UPTRAVI® in triple combination therapy provides long-term benefits *

When administered in triple combination therapy, UPTRAVI® reduced the risk of a morbidity-mortality event by 37% vs placebo compared with an endothelin receptor antagonist (ERA) and a phosphodiesterase type-5 inhibitor (PDE-5i) alone.*‡[15]

*Post hoc analysis of patients in GRIPHON on background therapy with an ERA and a PDE-5i at baseline.[15]
As measured by a composite primary endpoint. Results do not apply to mortality on its own (HR 0.63; 95% CI: 0.44–0.90).[15]

Uptravi_home_graph3

Proactively initiating UPTRAVI® earlier can give your patients even more time

UPTRAVI® reduced the risk of a morbidity-mortality event vs placebo in patients treated early (≤6 months from diagnosis) and those treated later (>6 months after diagnosis), with a greater effect when treated earlier (p=0.0219).*[13]

*Post hoc analysis in time-from-diagnosis subgroups in GRIPHON. Early: (HR 0.45; 95% CI: 0.33–0.63), later: (HR 0.74; 95% CI: 0.57–0.96).[13]
As measured by a composite primary endpoint. Results do not apply to mortality on its own.[13]

UPTRAVI® is shown to improve and maintain patient risk status in both clinical and real-world settings

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In the GRIPHON trial, UPTRAVI® patients were 69% more likely to increase their number of low-risk criteria vs placebo.*[14]

*Post hoc analysis assessing whether treatment with UPTRAVI® improved risk profile from baseline compared with placebo in the GRIPHON population using the non-invasive French approach and REVEAL 2.0.[14]
Change in number of low-risk criteria over time in the non-invasive French risk assessment subgroup (OR 1.69; 95% CI: 1.28–2.24; p=0.0002).[14]

uptravi_home_graph5

In the real-world SPHERE registry, 85% of patients improved or maintained their baseline risk status after 1 year.*[9]

*From the first 250 patients enrolled in SPHERE, an ongoing US-based observational registry of UPTRAVI®-treated patients with PAH.[9]
Based on patients who had risk assessment at both baseline and 1 year (196 patients or 78% of the total population).[9]

The overall treatment goal in PAH is to achieve a low-risk status,[11] which is shown to be prognostic for better long-term outcomes.[9][14][16]

Explore the full UPTRAVI® efficacy data

Learn more about UPTRAVI®

Safety and tolerability

UPTRAVI® has a well-characterised and generally manageable safety profile.[1][5]

Initiation and dosing

Adding UPTRAVI® is recommended at the first sign of intermediate risk.[11][12]

Expert consensus opinion

Learn about the patient profiles identified as benefiting from early UPTRAVI® initiation.[17]

Explore Janssen's PAH therapies

Built on ground-breaking innovation and an unwavering commitment to patients, we have created a range of therapeutic solutions to support patients throughout their PAH journey.

CI, confidence interval; EMA, European Medicines Agency; ERA, endothelin receptor antagonist; ERS, European Respiratory Society; ESC, European Society of Cardiology FC, functional class; FDA, Food and Drug Administration; HR, hazard ratio; IP, prostacyclin; OR, odds ratio; PAH, pulmonary arterial hypertension; PDE-5i, phosphodiesterase type-5 inhibitor; WHO, World Health Organization

UPTRAVI® PRESCRIBING INFORMATION AND ADVERSE EVENT REPORTING

OPSUMIT® PRESCRIBING INFORMATION AND ADVERSE EVENT REPORTING

VELETRI® PRESCRIBING INFORMATION AND ADVERSE EVENT REPORTING

CP-220222 | May 2021

References

UPTRAVI® SmPC, February 2021. Available at: https://www.ema.europa.eu/en/documents/product-information/uptravi-epar-product-information_en.pdf (last accessed May 2021).
Kuwano K et al. J Pharmacol Exp Ther 2007; 322(3):1181–1188.
Bruderer S et al. Pharmacology 2014; 94(3–4):148–156.
Simonneau G et al. Eur Respir J 2012; 40(4):874–880.
Sitbon O et al. N Engl J Med 2015; 373(26):2522–2533.
Panagiotidou E et al. Expert Opin Pharmacother 2021; 22(1):29–36.
UPTRAVI® US PI, January 2021. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207947s008lbl.pdf (last accessed May 2021).
Muller A et al. Presented at International Society for Pharmacoeconomics and Outcomes Research Europe Conference; 2–6 November 2019; Copenhagen, Denmark (Poster no. PDG37).
Farber HW et al. Presented at the American Thoracic Society Congress; 17–22 May 2019; Dallas, TX, USA (Poster no. 10769).
Janssen Data on File PAH/DOF/MAR2020/EMEA001, April 2021.
Galiè N et al. Eur Heart J 2016; 37(1):67–119.
Galiè N et al. Eur Respir J 2019; 53(1):1801889.
Gaine S et al. Chest 2021; doi: 10.1016/j.chest.2021.01.066.
Sitbon O et al. J Heart Lung Transplant 2020; 39(4):300–309.
Coghlan JG et al. Am J Cardiovasc Drugs 2018; 18(1):37–47.
Boucly A et al. Eur Respir J 2017; 50(2):1700889.
McLaughlin VV et al. Chest 2020; 157(4):955–965.