EMA completes safety review of Uptravi

The European Medicines Agency (EMA) has concluded its review of Uptravi (selexipag) for the treatment of pulmonary arterial hypertension (PAH), confirming it can be continued to be used, according to the prescribing information.

This review was initiated as a result of the death of five patients in France. During the review the Pharmacovigilance Risk Assessment Committee (PRAC) for the EMA closely examined the five deaths and studied the safety data collected since the medicine had started being marketed. Additionally, clinical trial data was analysed and comparisons were made with data from other PAH medicines.

It was concluded by PRAC that there is no increased mortality risk with Uptravi and the death rate of the medicine is in line with other PAH treatments. No specific regulatory action is required for Uptravi at this time but the safety of the drug will be monitored and data from ongoing and planned studies will be carefully evaluated.