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Label extension for Actelion

US regulators have expanded approval for Actelion's Tracleer to the treatment of patients with pulmonary arterial hypertension at an earlier stage of the disease

US regulators have expanded approval for Actelion's Tracleer (bosentan) to include the treatment of patients with pulmonary arterial hypertension (PAH) at an earlier stage of the disease.

The approval will allow the drug to be prescribed for those with mildly symptomatic World Health Organisation (WHO) functional class (FC) II PAH as well as its current use in patients with advanced or functional class III and IV PAH.

Kirk Taylor, senior vice president, US Medical Group at Actelion Pharmaceuticals US, said: "The Food and Drug Administration's (FDA) 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."

Actelion is trying to cut its dependence on Tracleer, which treats heart and lung disease and generates revenue of $1bn a year, by developing it in new indications and pushing other new drugs to market.

In addition, the FDA approved a 20 microgram per millilitre formulation of Ventavis for Class III and IV PAH. It said the increased strength formula would deliver the same dose in half the volume, which should reduce inhalation time.

11th August 2009

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