The European Medicines Agency has okayed selexipag (Uptravi, Actelion) for the treatment of pulmonary arterial hypertension after concern over the deaths of 5 patients prescribed the drug in France, Medscape reports. 

Selexipag was approved in the European Union in May 2016 and in the United States in December 2015.

In their review of selexipag, the PRAC closely examined the five fatal cases and analyzed relevant safety data collected since approval of the drug, as well as data from clinical trials and comparisons with data from other drugs for PAH.

“The PRAC concluded that the data examined do not suggest any increase in mortality with Uptravi, and the death rate in patients taking Uptravi is in line with observations for other PAH medicines,” the EMA said in a statement.

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