GSK’s Volibris gets pulmonary arterial hypertension approval in Europe
pharmafile | October 26, 2015 | News story | Research and Development, Sales and Marketing | EMA, GSK
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for a variation to expand the current therapeutic indication for GSK’s Volibris (ambrisentan) to include its use in combination treatment for patients with pulmonary arterial hypertension (PAH).
This positive opinion was based on data from the Phase 3b/4 AMBITION study, the first and only outcomes study to compare the efficacy and safety of investigational first-line combination therapy of ambrisentan and tadalafil to first-line monotherapy of either treatment alone in treatment-naïve patients with PAH.
The study showed the combination of ambrisentan and tadalafil reduced the risk of clinical failure by 50% in treatment-naive PAH patients, compared to pooled ambrisentan and tadalafil monotherapy. AMBITION was co-sponsored by GSK and Gilead, with additional support provided by Eli Lilly.
Jonathan Langley, clinical investigation lead PAH, GSK rare diseases, says: “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.
“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.”
The positive opinion is a formal recommendation by the CHMP to expand the existing marketing authorisation for ambrisentan to include combination treatment. A final decision from the European Commission is anticipated by December 2015.
Yasmita Kumar
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