A new long-term treatment for patients with pulmonary arterial hypertension has been approved for use within the European Union.
Selexipag (Uptravi) has been granted marketing authorisation by the European Commission for treating pulmonary arterial hypertension, which affects 6,000-7,000 people in the UK.
“Uptravi represents a major step forward in disease management”
The drug, manufactured by Actelion Pharmaceuticals UK, is a selective IP prostacyclin receptor agonist.
It is as an orally active agent that targets the prostacyclin pathway and has been licensed for the long-term treatment of pulmonary arterial hypertension in adult patients with WHO functional class (FC) II-III.
It has been approved for use 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.
The safety and efficacy of selexipag was evaluated in the GRIPHON trial, a long-term, placebo-controlled study involving 1,156 patients with symptomatic pulmonary arterial hypertension.
Patients were exposed to the drug for up to 4.2 years, with a median duration of 1.4 years.
The study found the drug delayed the time to the first morbidity or mortality event compared to placebo.
The most commonly reported adverse reactions were headache, diarrhoea, nausea and vomiting, jaw pain, myalgia, pain in extremity, arthralgia and flushing.
Diane Moran, a pulmonary hypertension clinical nurse specialist at Mater Misericordiae University Hospital in Dublin was one of the GRIPHON trial co-ordinators.
She said the selexipag represented a “major step forward” in disease management, offering patients an oral treatment that effectively targeted the prostacyclin pathway.
“Pulmonary arterial hypertension is a progressive and devastating disease, so the availability of new and innovative therapies to delay disease progression is absolutely fundamental for this community,” she said.
She noted that the “next step” was to secure approval from bodies such as the National Institute for Health and Care Excellence and the Scottish Medicines Consortium.