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news.GlaxoSmithKline has announced that the European Commission has issued marketing authorization for Volibris for the treatment of pulmonary arterial hypertension in patients classified as World Health Organization Functional Class II and III, to improve exercise capacity.
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Efficacy has been shown in idiopathic pulmonary arterial hypertension (PAH) and in PAH associated with connective tissue disease. Volibris (ambrisentan) offers the convenience of a once-daily oral tablet in two doses, 5mg and 10mg. The first European launches are planned for the summer of 2008 and negotiations are ongoing with individual markets.
Ambrisentan is said to be the first non-sulphonamide class endothelin receptor antagonist and the first PAH medicine approved for WHO Functional Class II patients in Europe.