EU's CHMP recommends expanding indication for Volibris (ambrisentan) as combination treatment for pulmonary arterial hypertension- GlaxoSmithKline

GlaxoSmithKline has announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a positive opinion for a variation to expand the current therapeutic indication for Volibris (ambrisentan) to include its use in combination treatment for patients with pulmonary arterial hypertension (PAH). A final decision from the European Commission is anticipated by December 2015.

This positive opinion was based on data from the Phase IIIb/IV AMBITION study, which compared the efficacy and safety of investigational first-line combination therapy of ambrisentan and tadalafil to first-line monotherapy of either treatment alone, in treatment-naïve patients with PAH. The study was recently published in the New England Journal of Medicine and showed that the combination of ambrisentan and tadalafil reduced the risk of clinical failure by 50% in treatment-naïve PAH patients compared to pooled ambrisentan and tadalafil monotherapy.