GlaxoSmithKline receives CHMP backing for new Volibris indication

GlaxoSmithKline has announced that its drug Volibris has been endorsed for approval in a new indication.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion for a variation to expand the current indication for Volibris to include its use in combination treatment for pulmonary arterial hypertension patients.

Data from the phase IIIb/IV AMBITION study offered evidence of the efficacy and safety of Volibris and tadalafil as an investigational first-line combination therapy when compared to first-line monotherapy with either treatment alone.

The combination of Volibris and tadalafil was shown to reduce the risk of clinical failure by 50 percent in treatment-naive patients compared to pooled Volibris and tadalafil monotherapy.

Jonathan Langley, clinical investigation lead for pulmonary arterial hypertension for GlaxoSmithKline's rare diseases division, said: "If approved, this could help improve clinical outcomes for patients across Europe suffering from this rare condition. We look forward to receiving a final decision from the European Commission in the coming months."

A final decision on approval of the drug in this new indication is anticipated by December 2015.