GSK announced that the European Commission has approved a variation to expand the current therapeutic indication for Volibris® (ambrisentan) to include its use in combination treatment for patients with pulmonary arterial hypertension (PAH). Volibris is indicated for treatment of PAH in adult patients of WHO Functional Class (FC) II to III, including use in combination treatment.
This decision was based on data from the Phase 3b/4 AMBITION study, which showed that the combination of ambrisentan and tadalafil reduced the risk of clinical failure by 50% in treatment-naïve PAH patients compared to pooled ambrisentan and tadalafil monotherapy (p=<0.001).
“PAH is a rare, chronic and life-changing disease that can result in heart failure and death if left untreated. 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 Jonathan Langley, Clinical Investigation Lead for PAH at GSK.
AMBITION was 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.
AMBITION was co-sponsored by GSK and Gilead, with support provided by Eli Lilly.
Further regulatory submissions to include the AMBITION data in the ambrisentan label are ongoing and planned in other countries.
