Tracleer receives approval for new indication

Published: 12-May-2008
Regulatory

Actelion Pharmaceuticals" Tracleer (bosentan), a dual endothelin receptor antagonist, has been approved in the UK and Ireland for the reduction of the number of new digital ulcers (DUs) in patients with systemic sclerosis (SSc) and ongoing DU disease.1


Actelion Pharmaceuticals" Tracleer (bosentan), a dual endothelin receptor antagonist, has been approved in the UK and Ireland for the reduction of the number of new digital ulcers (DUs) in patients with systemic sclerosis (SSc) and ongoing DU disease.1

DUs are a frequent, painful and disabling complication of SSc,2 caused by a reduced blood flow to the fingers and toes. Research indicates that up to 50% of SSc patients develop DUs.2

Tracleer targets the underlying vasculopathy in SSc by blocking the damaging effects of endothelin. The new indication extends the previous licence of Tracleer for the treatment of pulmonary arterial hypertension (PAH).

"Digital ulcers can be severely disabling as well as extremely painful, affecting people's ability to undertake activities of everyday living and interfering with their working and social lives," said Dr Arianne Herrick, Reader of Rheumatology at the University of Manchester.

"This new indication offers a valuable therapy for patients with scleroderma and ongoing digital ulceration, to help reduce the number of new ulcers."

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