EMA Safety Review Clears Selexipag (Uptravi)

Megan Brooks

April 07, 2017

The European Medicines Agency (EMA) confirmed today that clinicians in Europe can continue to prescribe selexipag (Uptravi, Actelion) to both new and existing patients in accordance with current prescribing information.

In February, the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) launched a formal review of the safety of selexipag after the deaths of five patients taking the drug in France.

The agency has now completed its review, concluding that no changes to the prescribing information are considered necessary.

Selexipag is used to treat adults with pulmonary arterial hypertension (PAH), a chronic and progressive rare lung disease that can lead to premature death or the need for transplantation.

Selexipag is an oral selective prostacyclin receptor agonist that relaxes muscles in the walls of blood vessels to dilate blood vessels and decrease the elevated pressure in the vessels supplying blood to the lungs.

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

"No specific regulatory action is considered necessary for Uptravi at this time.  The safety of Uptravi will continue to be monitored, and emerging data from ongoing and planned studies will be carefully evaluated as they become available," the agency said.

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