For U.S. Healthcare Professionals
OPSUMIT® (macitentan) milestones from the past, present, and future
The ongoing commitment of Actelion, a Janssen Pharmaceutical Company, to advancing the treatment of PAH
2008
Recruitment for the SERAPHIN clinical trial begins1
2013
FDA approves OPSUMIT® as the first oral once-daily ERA with long-term (average treatment duration 2 years) outcomes data2,3
2017
Presented open-label extension data to add to the understanding of the long-term use of OPSUMIT®2,4
2022
More than 45,000 patients prescribed OPSUMIT® in the United States, since approval in 20135*
ONGOING
Continued commitment to PAH through:
- Patient support
- Clinical research including numerous, ongoing phase 2 and 3 clinical trials
Learn about the proven efficacy of OPSUMIT®
See Seraphin ResultsSERAPHIN PAH-related hospitalization results
View the DataView SERAPHIN PAH-CTD subgroup data
See the Data*As of December 2022.
ERA=endothelin receptor antagonist;
PAH=pulmonary arterial hypertension;
SERAPHIN=Study with an Endothelin Receptor Antagonist in Pulmonary Arterial Hypertension to Improve CliNical Outcome.
References:
1. 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 October 14, 2022. https://clinicaltrials.gov/ct2/show/NCT00660179
2. OPSUMIT® [prescribing information]. Actelion Pharmaceuticals US, Inc.
3. Data on file. Actelion Pharmaceuticals US, Inc.
4. Souza R, Delcroix M, Galié 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.
5. Data on file. Actelion Pharmaceuticals US, Inc., as of December 2022.