GSK's Volibris (ambrisentan), EMEA positive opinion for approval to treat class II and II pulmonary arterial hypertension (PAH)

Thursday 21st February 2008 - GlaxoSmithKline (GSK) announced that Volibris^® (ambrisentan) has received a positive opinion from the European Committee for Human Medicinal Products (CHMP) for the treatment of Pulmonary Arterial Hypertension (PAH) in patients classified as World Health Organisation (WHO) Functional Class II and III, to improve exercise capacity¹. Approval by the European Commission and Marketing Authorisation is expected to be granted by the end of April 2008.
Ambrisentan, a non-sulphonamide class endothelin receptor antagonist (ERA), is the first PAH medicine indicated for WHO Functional Class II patients in Europe...GSK's Press Release-