Actelion has received another approval from regulators in the USA for its pulmonary arterial hypertension blockbuster Tracleer to be used for early-stage treatment of the disease.

Specifically, the US Food and Drug Administration has approved the Swiss company's supplemental New Drug Application for Tracleer (bosentan) to treat patients with mildly symptomatic ‘functional class II’ pulmonary arterial hypertension. In March the agency sent Actelion a complete response letter informing the firm that its risk evaluation and mitigation strategy needed further analysis.

The FDA has also now approved Actelion's REMS for Tracleer, which is already available for patients with more advanced, FC III and IV PAH. Jean-Paul Clozel, the company’s chief executive, said it is good news that patients now have access to the therapy when in the early stages of this “rapidly progressing and life-threatening disease”. He added that the label extension is based on data from the EARLY trial, which demonstrate that Tracleer “significantly reduces risk of clinical worsening in early-stage patients, thereby slowing down disease progression”.

Tracleer accounts for around 90% of Actelion’s total revenue, and second-quarter sales increased 22% to 387 million Swiss francs. This latest PAH label extension will do no harm to turnover but sales would rise dramatically if the company manages to get FDA approval for Tracleer as a treatment for idiopathic pulmonary fibrosis.
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Actelion also announced that the FDA has approved a 20mcg/ml formulation of Ventavis (iloprost), an inhaled therapy for the treatment of PAH for Class III and IV PAH. The Allschwil-based firm said the increased strength formulation would deliver the same dose in half the volume, “which is expected to reduce inhalation time and further support patient compliance”.