The European Commission has approved a variation to expand the current therapeutic indication for GlaxoSmithKline’s (GSK) Volibris (ambrisentan) to include its use in combination treatment for patients with pulmonary arterial hypertension (PAH).
The drug is indicated to treat PAH in adults of WHO Functional Class (FC) II to III, including use in combination treatment.
Approval was based on data from the Phase IIIb/IV 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.
GlaxoSmithKline PAH clinical investigation lead Jonathan Langley said: "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."
The AMBITION study has compared 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 was co-sponsored by GSK and Gilead, with support provided by Eli Lilly and Company.
Ambrisentan is a selective endothelin type-A receptor antagonist and is approved in the European Union (EU) and other countries as a once-daily treatment for PAH, (WHO Group 1) in patients with WHO/NYHA functional class II and III symptoms.
GSK commercialises ambrisentan under the tradename Volibris in territories outside of the US, while Gilead commercialises the product as Letairis in the US.
Ambrisentan has been granted orphan drug status to treat PAH in Australia, Europe, Japan, Korea and the US.
Image: Micrograph showing a plexiform lesion of the lung, as seen in irreversible pulmonary hypertension. Photo: courtesy of Patho.