GSK today announced that it has filed a regulatory submission to the European Medicines Agency (EMA) for a variation to the Marketing Authorisation for ambrisentan (Volibris), 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 naïve PAH patients with WHO functional class II and III symptoms.

PAH, a debilitating disease affecting approximately 200,000 patients worldwide, is characterised by constriction of the blood vessels in the lungs leading to high pulmonary arterial pressures.  These high pressures make it difficult for the heart to pump blood through the lungs to be oxygenated.  Patients with PAH suffer from shortness of breath as the heart struggles to pump against these high pressures, causing such patients to ultimately die of heart failure.

For more details, go to: http://www.gsk.com/en-gb/media/press-releases/2014/gsk-announces-eu-regulatory-submission-seeking-extended-indication-for-ambrisentan-volibris-in-pulmonary-arterial-hypertension/