European regulators are advising that doctors can continue prescribing Actelion’s Uptravi for pulmonary arterial hypertension while an investigation into its safety is completed.
Uptravi (selexipag) is currently used for long-term treatment of pulmonary arterial hypertension, a life-threatening condition involving abnormally high blood pressure in the arteries of the lung, affecting around 6,000-7,000 people in the UK.
It is authorised for use in combination with endothelin receptor antagonists (ERAs) and/or phosphodiesterase type 5 (PDE-5) inhibitors when these do not work well enough on their own, or as monotherapy in patients who cannot take these treatments.
The drug was approved centrally in Europe in May last year on the back of data from the Phase III GRIPHON study showing that Uptravi, a selective IP prostacyclin receptor agonist, delayed the time to a first morbidity or mortality event compared to placebo in patients with the condition.
But the deaths of five patients taking the drug in France has sparked a review to determine whether there are any new safety issues with the medicine.
After a preliminary look of the data, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has decided that Uptravi may continue to be used but strictly in line with current prescribing information.
The Committee is further exploring all available information, and said it will publish final conclusions once this is complete.
