GlaxoSmithKline (GSK) has applied for a European Medicines Agency (EMA) variation to the Marketing Authorization for ambrisentan (Volibris), in order to expand the currently approved indication to include its use as a first-line combination therapy with tadalafil for pulmonary arterial hypertension (PAH).
Ambrisentan is classified as a selective endothelin type-A receptor antagonist, which was previously approved in the European Union (EU) as a treatment for PAH classified as WHO functional class II and III to enhance tolerance for physical activity.
