Results of SERAPHIN, the pivotal study with Switzerland-based Actelion’s (SIX: ATLN) macitentan (trade name Opsumit) in patients with pulmonary arterial hypertension (PAH) have been published today (August 29) in the New England Journal of Medicine (NEJM), showing that the drug significantly reduced the risk of morbidity/mortality events.
Actelion, Europe’s largest biotechnology company, says that macitentan, seen as a replacement for its leading marketed drug, the PAH treatment Tracleer (bosentan), sales of which are falling due to the competitive situation in the USA, is currently in worldwide regulatory review.
Tomas Pulido, Professor of Medicine and dead of the Cardiopulmonary Department, Ignacio Chavez National Heart Institute, Mexico City, primary author of the NEJM paper, commented: "I am very proud to be part of this exceptional study. The results published today in the NEJM show valuable long-term morbidity/mortality data from SERAPHIN, the largest-ever trial in PAH. I expect this landmark study to set a new standard in how the evidence for PAH therapies is measured."
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