The European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use has given a positive opinion to GlaxoSmithKline’s (GSK) Volibris for Class II and III pulmonary arterial hypertension (PAH). Final marketing approval is expected by the end of April.

Volibris (ambrisentan) is a nonsulphonamide class endothelin receptor antagonist meant to improve patients’ exercise capacity. It is the first PAH medicine indicated for World Health Organization functional Class II PAH patients in Europe.

Treatment with the drug resulted in significant improvement in exercise capacity (six-minute walking distance) and beneficial changes to other, more technical disease parameters in two randomized, double-blind, placebo-controlled, 12-week-long Phase III trials that enrolled a total of 393 patients. It will be available as a once-daily oral tablet in 5- and 10-mg doses, according to GSK.