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news.GlaxoSmithKline (GSK) has submitted a regulatory application to the European Medicines Agency (EMA) to widen the uses for which its pulmonary arterial hypertension (PAH) treatment ambrisentan (Volibris) can be marketed.
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The application seeks to extend the current therapeutic indication to include its use in initial combination therapy for PAH patients.
PAH is characterized by constriction of the blood vessels in the lungs leading to high pulmonary arterial pressures.
The submission is based on the results of the Phase IIIb/IV AMBITION trial, conducted in collaboration with biotechnology firm Gilead Sciences.
Gilead studied the initial combination therapy of ambrisentan and tadalafil in treatment naïve PAH patients with WHO functional class II and III symptoms.
GSK senior vice president and head of Rare Diseases Research & Development Dr Carlo Russo said: "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.
"This submission has been part of our efforts to continue to help patients with pulmonary arterial hypertension and we look forward to the outcome."
According to the company, further regulatory submissions are planned in other countries during the course of 2014 and 2015.
Ambrisentan is currently approved in the EU to treat adults with PAH classified as WHO functional class II and III, to improve exercise capacity.
GSK commercializes ambrisentan under the trade name Volibris in territories outside of the US, while Gilead commercializes it as Letairis in the US.
Image: GlaxoSmithKline headquaters in London, UK. Photo: courtesy of Maxwell Hamilton.