GlaxoSmithKline receives EU approval for expanded Volibris indication

GlaxoSmithKline has received approval from the European Commission for an expanded indication for its drug Volibris.

A variation to expand the current therapeutic indication for Volibris to include its use in combination treatment for patients with pulmonary arterial hypertension has been ratified by the regulator this week.

Data from the phase IIIb/IV AMBITION study showed that the combination of Volibris and tadalafil reduced the risk of clinical failure by 50 percent in treatment-naive hypertension patients compared to pooled Volibris and tadalafil monotherapy.

The findings of this study will also be used to support future regulatory applications for the drug.

Jonathan Langley, clinical investigation lead for pulmonary arterial hypertension at GlaxoSmithKline, said: "The expanded authorisation for Volibris will make an important difference to the future management of pulmonary arterial hypertension and the outcomes of patients living with this highly debilitating condition."

The therapy has been granted orphan drug status in Australia, Europe, Japan, South Korea and the US. It is commercialised by Gilead under the brand name Letairis in the US market.