The commission approved a variation of the drug to expand the existing therapeutic indication for Volibris, which can now be used as part of a combination treatment for patients with PAH.
Volibris is indicated to treat PAH in adult patients of WHO Functional Class (FC) II to III, including use in combination treatment.
The approval was based on data from the company’s Phase 3b/4 study, dubbed Ambition, which demonstrated that ambrisentan in combination with tadalafil decreased the risk of clinical failure by 50% in treatment-naïve PAH patients compared to pooled monotherapy of the drugs.
The study has also 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 hospitalization for patients, compared to either treatment given individually.
GSK clinical investigation lead for PAH Jonathan Langley said: "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."
GSK and Gilead co-sponsored the Ambition study with support from by Eli Lilly. Additional regulatory submissions to include the study data in the ambrisentan label are ongoing and planned in other countries.
Ambrisentan has been granted orphan drug status to treat PAH in Australia, Europe, Japan, Korea and the US.