CHMP backs expanded use of GSK's Volibris for PAH

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for a variation to expand the current therapeutic indication for UK Pharma major GlaxoSmithKline’s (LSE: GSK) Volibris(ambrisentan) to include its use in combination treatment for patients with pulmonary arterial hypertension (PAH).

“Today’s decision represents an important milestone for the PAH community, supporting the potential for initial combination treatment in this highly debilitating and limiting disease,” said Jonathan Langley, clinical investigation lead PAH, GSK Rare Diseases. “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,” he noted.

Clinical backing