SOUTH SAN FRANCISCO, Calif. and ALLSCHWIL, Switzerland, March 15, 2019 /PRNewswire/ -- Actelion Pharmaceuticals US, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, announced today an interim analysis from the Right vEntricular Remodeling in Pulmonary ArterIal hypeRtension (REPAIR) study of OPSUMIT® (macitentan) that shows treatment with OPSUMIT in patients with pulmonary arterial hypertension (PAH) was associated with significant improvements in right ventricular (RV) function including reversal of RV remodeling and reduced pulmonary vascular resistance (PVR). The data are being OPSUMIT on RV remodeling and function as determined by cardiac magnetic resonance imaging (MRI) and right heart catheterization. OPSUM 15.2 mL mean increase (p<0.0001) in RV stroke volume (RVSV) and a 37% reduction (p<0.0001) in PVR from baseline at Week 26. OPSUMIT is associated with significantly improved RV function as determined by MRI in patients with PAH. In the REPAIR study, the safety profile of OPSUMIT was consistent with previous clinical trial data.These results add to the growing body of research into understanding OPSUMIT in PAH.
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*Drs. Rosenkranz and Channick have received research support from Actelion and have served as paid consultants to the company.
Notes to the Editor REPAIR STUDY
The Right vEntricular Remodeling in Pulmonary ArterIal hypeRtension (REPAIR) study is a 52-week, open-label, multicenter study evaluating the effect of OPSUMIT on right ventricular (RV) remodeling and function as determined by cardiac MRI and right heart catheterization. REPAIR is the first multicenter study in PAH to use a primary endpoint measured by MRI enabling clinicians to further understand the direct effects of OPSUMIT on RV remodeling and function in patients with PAH.
In the REPAIR study, OPSUMIT was initiated as monotherapy or sequential combination therapy with a phosphodiesterase-type 5 (PDE-5) inhibitor or as initial combination therapy with a PDE-5 inhibitor. The two primary endpoints were (1) change in RVSV from baseline to Week 26, determined by pulmonary artery flow MRI, and (2) change in PVR from baseline to Week 26 measured by right heart catheterization. In the pre-specified interim analysis including the first 42 patients enrolled, RVSV was significantly increased (mean change 15.2 ml, 96% CI [9.3; 21.0], p<0.0001) and PVR was significantly decreased (37%, 99% CI [26; 46], p<0.0001) at Week 26. The study was declared positive and enrollment was stopped. All enrolled patients remain in the study up to their 52-week assessments, and a supportive final analysis will be presented when the results become available.
The REPAIR study showed that treatment with OPSUMIT was associated with significant improvement in RV function in patients with PAH.
What is OPSUMIT® (macitentan)?
OPSUMIT is a prescription medicine used to treat pulmonary arterial hypertension (PAH, WHO Group 1). PAH is high blood pressure in the arteries of your lungs. OPSUMIT can:
- Improve your ability to exercise as measured by the 6-minute walk distance (6MWD). In a clinical study of mainly WHO FC II-III patients, those taking OPSUMIT walked, on average, 22 meters farther at Month 6 than patients not taking it
- Improve some of your symptoms
- Help slow down the progression of your disease
- 1.
Who should not take OPSUMIT? or.
Please see full Prescribing Information and Medication Guide, including an Important Warning about Serious Birth Defects at.
ABOUT ACTELION
Actelion, a leader in Pulmonary Arterial Hypertension, became part of the Janssen Pharmaceutical Companies of Johnson & Johnson following its acquisition in June 2017. within this rare disease area. Learn more at. Follow us at @actelion. Actelion Pharmaceuticals US, Inc. is one of the Janssen Pharmaceutical Companies of Johnson & Johnson.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding the development of OPSUMIT® (macitent US,
- Rosenkranz S et al. Effects of Macitentan on Right Ventricular Remodeling in Pulmonary Arterial Hypertension: Results From the REPAIR Study Interim Analysis. Proceedings from the American College of Cardiology; March 16-18, 2019; New Orleans, LA. Abstract 902-06.
- OPSUMIT (macitentan) Summary of Product Characteristics. Actelion Pharmaceuticals Ltd. September 2018.
- OPSUMIT (macitentan) full Prescribing Information. Actelion Pharmaceuticals US, Inc. October 2018.
- SERAPHIN Trial (Pulido et al. NEJM 2013).
- Pulido T et al. Macitentan and Morbidity and Mortality in Pulmonary Arterial Hypertension. N Engl J Med 2013;369:809-18.
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- Iglarz M. et al. Pharmacology of macitentan, an orally active tissue targeting dual endothelin receptor antagonist. J Pharmacol Exp Ther. 2008;327(3):736-745.
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SOURCE Actelion Pharmaceuticals US, Inc.