Actelion Ltd announced that the US Food and Drug Administration (FDA) has approved the company's supplemental New Drug Application (sNDA) for Tracleer (bosentan) to treat patients with mildly symptomatic WHO Functional Class II (FC II) pulmonary arterial hypertension (PAH). The US FDA has also approved Actelion's Risk Evaluation and Mitigation Strategy (REMS) for Tracleer.

Jean-Paul Clozel, MD and chief executive officer of Actelion said, "Physicians in the United States of America who treat PAH patients now have access to Tracleer as an approved therapy for patients not only in advanced, but also in the early stages of this rapidly progressing and life-threatening disease. This label extension is based on EARLY, the only randomized, double blind, placebo controlled study in this mildly symptomatic patient population. The EARLY results demonstrate that Tracleer significantly reduces risk of clinical worsening in early-stage patients, thereby slowing down disease progression."

Vallerie McLaughlin, associate professor of Medicine, director, Pulmonary Hypertension Program, University of Michigan Health System added, "PAH is a progressive and devastating disease, and patients are not always treated as early as they should be with therapies that can impact disease progression. The approval of Tracleer for the treatment of patients with early-stage disease, offers physicians a new, proven therapy that may result in beneficial clinical outcomes."

Kirk Taylor, senior vice president, US Medical Group at Actelion Pharmaceuticals US, Inc. commented, "The FDA's approval of Tracleer for use in patients with early-stage PAH provides the opportunity to improve clinical outcomes. Tracleer is the only PAH medication that has consistently shown significantly reduced risk of clinical worsening in PAH patients in three separate phase-III studies."

Tracleer is an oral dual endothelin receptor antagonist approved for the treatment of PAH FC II, III and IV in the US and for the treatment of PAH FC II and III in the EU. The company is working with authorities on a worldwide basis to expand the label for Tracleer to include patients with FC II PAH.

The objectives of the prospective, randomized, placebo-controlled, multicenter EARLY (Endothelin Antagonist tRial in miLdlY symptomatic PAH patients) trial were to gain more insights into early stage disease and to investigate the effects of bosentan specifically in patients with WHO FC II PAH.

Actelion is a biopharmaceutical company with its corporate headquarters in Allschwil/Basel, Switzerland. Actelion's first drug Tracleer, an orally available dual endothelin receptor antagonist, has been approved as a therapy for pulmonary arterial hypertension.