GlaxoSmithKline files for EU extended indication for Volibris in PAH

UK pharma major GlaxoSmithKline (LSE: GSK) says it has filed a regulatory submission to the European Medicines Agency for a variation to the Marketing Authorization 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 (Nasdaq: GILD), which investigated the initial combination therapy of ambrisentan and tadalafil in treatment naïve PAH patients with WHO functional class II and III symptoms.

“We hope that evidence from the AMBITION study, which showed that starting initial combination of ambrisentan and tadalafil was superior to first-line monotherapy with either medicine alone, will help support the management of patients who suffer with this rare and debilitating lung disease,” said Carlo Russo, senior vice president and head of GSK Rare Diseases Research & Development, adding: “This submission has been part of our efforts to continue to help patients with pulmonary arterial hypertension and we look forward to the outcome.”