LONDON (Alliance News) - GlaxoSmithKline PLC said Tuesday that its Volibris drug has been approved for the use in combination therapy for pulmonary arterial hypertension in Europe, an expansion of its current therapeutic indication.
This approval was based on data from the company's Phase 3b/4 study, dubbed AMBITION, which showed that the drug in combination with tadalafil reduced the risk of clinical failure by 50% in patients who have never undergone treatment for pulmonary arterial hypertension compared to treatment with the drugs on their own.
"The AMBITION study has demonstrated that the early combination of two treatments that target different pathways in PAH can halve the risk of clinical failure and more than half the rate of hospitalisation for patients, compared to either treatment given individually. The expanded authorisation for Volibris will make an important difference to the future management of PAH and the outcomes of patients living with this highly debilitating condition," said Clinical Investigation Lead for PAH at Glaxo Jonathan Langley in a statement.
Shares in Glaxo were down 1.3% at 1,328.25 pence Tuesday afternoon.
By Hana Stewart-Smith; hanassmith@alliancenews.com; @HanaSSAllNews
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