EMA to review safety of Uptravi (selexipag) a treatment for pulmonary arterial hypertension.- Actelion/J&J

The European Medicines Agency (EMA) is reviewing the safety of Uptravi (selexipag) from Actelion/J&J, following the deaths of 5 patients taking the medicine in France. Uptravi is used to treat pulmonary arterial hypertension (a life-threatening condition involving abnormally high blood pressure in the arteries of the lungs). Based on a preliminary review of available data, EMA advises that Uptravi may continue to be used, both in existing and new patients, but use must be in line with the current prescribing information. EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) will further explore all available data. Once the review is completed, final conclusions will be published.

Comment: Actelion is in the process of being sold to Johnson & Johnson. Uptravi is a follow on to Actelion's Tracleer (bosentan) whose patent expired in November 2015.