Tracleer wins wider EU licence
pharmafile | August 8, 2008 | News story | Sales and Marketing |Â Â Â
Actelion's Tracleer (bosentan) has been approved in Europe to treat patients with mildly symptomatic pulmonary arterial hypertension (PAH).
The move represents a substantial widening of Tracleer's EU licence, which for the past six years has only covered patients with a more severe form of PAH.
A dual endothelin receptor antagonist, Tracleer is already established as a significant earner for the Swiss pharma group, representing half its revenue in the first half of 2008.
While PAH is rare, it is serious and is marked by a progressive increase in pulmonary vascular resistance (PVR) leading to right ventricular failure and premature death if untreated.
Actelion says its research highlighted the need for earlier treatment and intervention in PAH management after some improvements in delaying disease progression were observed in a 185-patient randomised, double-blind, placebo-controlled study.
"The EARLY study has demonstrated that even patients with mild symptoms are at risk of rapid deterioration," said Actelion chief executive Jean-Paul Clozel. "Tracleer is the only PAH medicine to have demonstrated a delay in disease progression in three independent placebo-controlled, randomized clinical studies. Actelion will now communicate these important clinical findings to encourage early diagnosis and intervention."
Among the key trial findings were that PVR improved significantly, reduced by of 22.6% after six months of Tracleer versus placebo. There was also a 77% risk reduction in the time it took before "clinical worsening" – defined by symptomatic progression of PAH, hospitalization or death – over the same treatment period. Also, there was a 3.4% incidence of PAH worsening compared to 13.2% for patients receiving placebo.
Class II PAH patients – for whom Tracleer can now be used in the EU – are defined as having "mild" limitation of physical activity. Actelion is seeking a similar licence in the US, where the drug has so far been approved for Class III and IV patients.
The company has also pursued a number of other licence extensions for Tracleer. Last year the EU gave it marketing approval in the treatment of digital ulcers – open sores that can lead in extreme cases to the risk of amputation of fingers and toes.
