EMA Completes Postmarket Safety Review of Uptravi

Regulatory NewsRegulatory News | 07 April 2017 |  By 

Less than two months after launching a safety review of Actelion Pharmaceuticals' pulmonary arterial hypertension (PAH) drug, Uptravi (salexipag), the European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) says it did not find an increased risk of death associated with the drug.

In February, EMA advised doctors to closely follow the approved prescribing information for Uptravi after learning of the deaths of five patients taking the drug in France.

According to EMA, after closely investigating the five reported deaths and other relevant safety data from clinical trials and comparisons with other PAH drugs, the PRAC concluded there was no increased risk of death with Uptravi.

"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," EMA writes.

As such, EMA says that no regulatory action is necessary, and it will not require any changes to Uptravi's prescribing information.

However, the agency says it will continue to monitor Uptravi's safety and evaluate any new safety signals related to the drug.



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