Actelion's Tracleer gets US label extension

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

Jean-Paul Clozel, chief executive of Actelion commented: "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 and director of the Pulmonary Hypertension Program at the 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."

Tracleer is an oral dual endothelin receptor antagonist approved for the treatment of PAH FC II, III and IV in the US [1] and for the treatment of PAH FC II and III in the EU. [2] The company is working with authorities on a worldwide basis to expand the label for Tracleer® to include patients with FC II PAH.

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