For U.S. Healthcare Professionals

For adult patients with PAH WHO FC II-III

10 Years of OPSUMIT®—The #1 Most-Prescribed ERA Therapy in PAH Nationwide1,2*

Johnson & Jonhson is committed to providing treatment for patients with PAH

2008

Recruitment for the SERAPHIN clinical trial begins3

2013

FDA approves OPSUMIT® as an oral once‍-‍daily ERA with the first available set of long‍-‍term (average treatment duration 2 years) outcomes data1,4

2015

ESC/ERS Guidelines recommend OPSUMIT® added to sildenafil as an option for sequential combination therapy in PAH (WHO Group I) FC II‍-‍III5*

*

The 2022 ESC/ERS Guidelines supersede the 2015 edition.

2017

Long-term use of OPSUMIT® was presented in an open‍-‍label extension with data out to 7 years to add further understanding of outcomes1,6

2022

  • ESC/ERS Guidelines recommend OPSUMIT® in initial and sequential combination therapy (Class I, Level B)7†‡

    • OPSUMIT® was not studied for initial combination therapy or in combination with oral prostanoids in the pivotal study SERAPHIN.3,8
  • More than 45,000 patients with PAH prescribed OPSUMIT® in the United States, since approval in 20139§

SERAPHIN pivotal trial

VIEW RESULTS

REPAIR study

EXPLORE ANALYSIS

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*Source: IQVIA NPA TRx (Q1 2023-Q4 2023) and US claims data based on total prescriptions and refills from January 2023 to December 2023 and October 2022 to September 2023, demonstrating that OPSUMIT® is the #1 most-prescribed branded ERA therapy in PAH Nationwide.

†Class I recommendation is evidence and/or general agreement that a given treatment or procedure is beneficial, useful, or effective. Level B evidence recommendation is data derived from a single randomized clinical trial or large nonrandomized studies.7

‡OPSUMIT® + tadalafil is recommended for initial combination therapy in patients with idiopathic, heritable, drug‍-‍associated PAH or PAH-CTD who have no cardiopulmonary comorbidities. The addition of OPSUMIT® to PDE5 inhibitors or oral/inhaled prostacyclin analogs is recommended for sequential combination therapy in patients with idiopathic, heritable, or drug-associated PAH who have no cardiopulmonary comorbidities. OPSUMIT® is not indicated for drug‍-‍associated PAH.1,7

§As of December 2022.

ERA=endothelin receptor antagonist; ERS=European Respiratory Society; ESC=European Society of Cardiology; FC=Functional Class; PAH=pulmonary arterial hypertension; PAH-CHD=PAH associated with congenital heart disease; SERAPHIN=Study with an Endothelin Receptor Antagonist in Pulmonary Arterial Hypertension to Improve CliNical Outcome; WHO=World Health Organization.
References: 1. OPSUMIT® (macitentan) full Prescribing Information. Actelion Pharmaceuticals US, Inc. 2. Data on file (December 2023). Actelion Pharmaceuticals US, Inc. Based on Express Scripts Pharmacy Benefits Manager Claims Data (from January 2023 to December 2023), Optum Clinformatics Extended Data Mart (from October 2022 to September 2023), proprietary claims data (from November 2022 to October 2023), and IQVIA NPA TRx Data (January 2023 to December 2023). 3. US Dept of Health and Human Services, National Institutes of Health, US National Library of Medicine. Study of Macitentan (ACT-064992) on Morbidity and Mortality in Patients With Symptomatic Pulmonary Arterial Hypertension (SERAPHIN). Accessed July 19, 2024. https://clinicaltrials.gov/ct2/show/NCT00660179 4. Data on file. Actelion Pharmaceuticals US, Inc. 5. Galiè N, Humbert M, Vachiéry J-L, et al. 2015 ESC‍/‍ERS Guidelines for the diagnosis and treatment of pulmonary hypertension: the Joint Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS). Eur Respir J. 2015;46(4):903-975. 6. Souza R, Delcroix M, Galiè N, et al. Long-term safety, tolerability and survival in patients with pulmonary arterial hypertension treated with macitentan: results from the SERAPHIN open-label extension. Adv Ther. 2022;39(9):4374-4390. 7. Humbert M, Kovacs G, Hoeper MM, et al; ESC/ERS Scientific Document Group. 2022 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension: the Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS). Eur Heart J. 2022;43(38):3618-3731. 8. Pulido T, Adzerikho I, Channick RN, et al; SERAPHIN Investigators. Macitentan and morbidity and mortality in pulmonary arterial hypertension. N Engl J Med. 2013;369(9):809-818 and suppl 1-21. doi:10.1056/NEJMoa1213917 9. Data on file. Actelion Pharmaceuticals US, Inc.

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