GSK seeks EU extension for Volibris in pulmonary arterial hypertension

GlaxoSmithKline (GSK) has filed a regulatory submission to the European Medicines Agency (EMA) to extend the Marketing Authorisation for Volibris (ambrisentan) for initial combination therapy for patients with pulmonary arterial hypertension (PAH).

GSK is hoping to get its respiratory portfolio back on track now its ailing blockbuster Advair/Seretide is failing against competition in asthma and chronic obstructive pulmonary disease, although its new products Breo (fluticasone furoate and vilanterol) and Anoro (umeclidinium and vilanterol) are taking longer than anticipated to carve out a space in the sector.

The current submission is based on the results of the phase IIIb/IV AMBITION study, conducted in collaboration with Gilead, which investigated ambrisentan and tadalafil in treatment naïve PAH patients with World Health Organization 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 Dr Carlo Russo, senior vice president, head of GSK Rare Diseases Research & Development.

PAH is a rare disease affecting approximately 200,000 patients worldwide and is characterised by constriction of the blood vessels in the lungs leading to high pulmonary arterial pressures. Patients suffer from shortness of breath as the heart struggles to pump against these pressures, ultimately causing death from heart failure.

Ambrisentan, a selective endothelin type-A receptor antagonist, is currently approved in the EU to improve exercise capacity in the same class of PAH patients. It has orphan drug status in Australia, Europe, Japan, Korea and the US.

Further regulatory submissions are planned in other countries in 2014 and 2015.

Link

GSK and Gilead's combination therapy: positive results in PAH