FDA has approved Actelion’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). FDA has also approved Actelion’s Risk Evaluation and Mitigation Strategy (REMS) for Tracleer .
Tracleer is an oral dual endothelin receptor antagonist 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.
Jean-Paul Clozel, MD and CEO 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.”