European regulators have ruled that Actelion’s Uptravi can continue to be used as per its prescribing information to treat patients with pulmonary arterial hypertension, a life-threatening condition involving abnormally high blood pressure in the arteries of the lungs affecting around 6,000-7,000 people in the UK.
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) undertook a safety review of Uptravi (selexipag) following the deaths of five patients in France, but concluded that the data do not suggest an increase in mortality linked with the drug.
Also, it said a review of the data confirmed that the death rate in patients taking Uptravi is in line with observations for other PAH medicines.
As a result, no changes to the prescribing information are considered necessary by the regulator. However, the safety of Uptravi will continue to be monitored, and emerging data from ongoing and planned studies will be carefully evaluated, it stressed.
The drug, a prostacyclin receptor agonist used for the long-term treatment of pulmonary arterial hypertension, was approved centrally in Europe in May last year for use in combination with endothelin receptor antagonists (ERAs) and/or phosphodiesterase type 5 (PDE-5) inhibitors when these medicines do not work well enough, or on its own in patients who cannot take these other treatments.
Approval was based on data from the Phase III GRIPHON study which showed that Uptravi delayed the time to a first morbidity or mortality event compared to placebo in patients with the condition.