Extention to indication of Volibris in PAH filed with EMA-GSK

Glaxo Smith Kline has filed a regulatory submission to the European Medicines Agency (EMA) for a variation to the Marketing Authorisation for Volibris (ambrisentan), to extend the current therapeutic indication to include its use in initial combination therapy for patients with Pulmonary Arterial Hypertension (PAH). The submission to the EMA is based on the results of the phase IIIb/IV AMBITION study, conducted in collaboration with Gilead Sciences Inc., which investigated the initial combination therapy of ambrisentan and tadalafil in treatment na�ve PAH patients with WHO functional class II and III symptoms. Further regulatory submissions are planned in other countries during the course of 2014 and 2015.