Actelion Pharmaceuticals UK has announced that Uptravi (selexipag), a selective IP prostacyclin receptor agonist, has been granted marketing authorisation for the long-term treatment of pulmonary arterial hypertension (PAH) in the EU by the European Commission.
Uptravi has been licensed for the long-term treatment of PAH in adult patients with WHO functional class (FC) II-III, either as a combination therapy in patients insufficiently controlled with an endothelin receptor antagonist (ERA) and/or a phosphodiesterase type 5 (PDE-5) inhibitor, or as monotherapy in patients who are not candidates for these therapies.
PAH is a chronic, life-threatening disorder affecting between 6,000-7,000 people in the UK. The condition is characterised by abnormally high blood pressure in the arteries between the heart and lungs of an affected individual. Advances in research mean the prognosis and treatment of PAH today has shifted to that of a long-term condition, however it remains a progressive, potentially devastating disease with high rates of morbidity and mortality.
The efficacy of Uptravi has been demonstrated in the GRIPHON trial, a long-term Phase III study in PAH patients with idiopathic and inherited PAH (58 per cent), PAH associated with connective tissue disorders (29 per cent) and PAH associated with corrected simple congenital heart disease (10 per cent).
Professor Sean Gaine, Consultant Respiratory Physician at Mater Misericordiae Hospital, Dublin, and one of the investigators participating in the GRIPHON trial commented, ‘For many years we have known that the prostacyclin pathway is a key target in PAH treatment, a pathway that has been underused largely due to the route of administration of the existing therapies.
‘An innovative, oral treatment, supported by long-term outcome results will allow us to offer convenient triple combination therapy regimens that target these three established treatment pathways. With this approach we not only aim to delay disease progression but we are looking for long-term benefits for our patients. Uptravi is a treatment option that could really change the way we treat PAH patients.’
