ALLSCHWIL, Switzerland I November 12, 2019 I Actelion Pharmaceuticals Ltd, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, has announced its decision to voluntarily withdraw the European and other health authority filings still under review to extend the indication of OPSUMIT® (macitentan) to include the treatment of adults with inoperable chronic thromboembolic pulmonary hypertension (CTEPH). This decision was not driven by any safety concerns. Actelion intends to generate additional data to support future CTEPH filings in Europe, U.S. and worldwide.

Feedback from health authorities, including in the U.S. and Europe, and from recent study site inspections indicated that additional clinical data would be required for approval. As a result, Actelion has decided to withdraw the ongoing worldwide submissions based on the Phase 2 study of Macitentan in thE tReatment of Inoperable chronic Thromboembolic pulmonary hypertension (MERIT-1). In the U.S., the Food and Drug Administration (FDA) issued a Complete Response letter earlier this year and Actelion is working with them to agree on next steps.

“We remain committed to addressing the high unmet needs that persist in this severe, life-limiting disease and will continue to study macitentan in this patient population,” said Martin Fitchet, M.D., Global Head, Actelion Research & Development, Janssen Research & Development, LLC.

Notes to the Editor
What is OPSUMIT® (macitentan)?1

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
  • Lower your chance of being hospitalized for PAH

It is not known if OPSUMIT is safe and effective in children.

ABOUT ACTELION
Actelion is the recognized global industry leader in pulmonary arterial hypertension (PAH, WHO Group 1), with a 20-year heritage of ground-breaking innovation that has helped transform the lives of more than 300,000 patients worldwide. In June 2017, Actelion became part of the Janssen Pharmaceutical Companies of Johnson & Johnson. Actelion’s medicines have helped to expand and strengthen Janssen’s portfolio with leading, differentiated in-market medicines and promising late-stage compounds. Janssen has added Pulmonary Hypertension as a therapeutic area of focus to maintain the leadership position Actelion has built in this important disease area. Learn more at www.actelion.com. Follow us on Twitter @actelion_com.

ABOUT THE JANSSEN PHARMACEUTICAL COMPANIES OF JOHNSON & JOHNSON
At Janssen, we are creating a future where disease is a thing of the past. We are the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology and Pulmonary Hypertension. Learn more at www.janssen.com. Follow us at www.twitter.com/JanssenGlobal.

Actelion Pharmaceuticals Ltd and Janssen Research & Development, LLC, are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

SOURCE: Actelion