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Home Industry News Actelion receives EMA clearing for continued use of Uptravi

Actelion receives EMA clearing for continued use of Uptravi

14th February 2017

Actelion Pharmaceuticals has received clearing from the European Medicines Agency (EMA) for the continued use of its pulmonary arterial hypertension drug Uptravi.

Concerns had been raised about the efficacy of the drug after five patients died during a trial in France, despite it having already been approved for use in Europe last May, after initial results demonstrated that Uptravi could improve outcomes for pulmonary arterial hypertension patients.

However, an investigation into these fatalities showed that they occurred in patients who were taking Uptravi on its own, when it is in fact designed for use alongside phosphodiesterase type 5 inhibitors or endothelin receptor antagonists.

As a result, the EMA's Pharmacovigilance Risk Assessment Committee ruled that Uptravi can continue to be used as a hypertension treatment, but that "patients taking Uptravi should follow their doctors' instructions" in order to ensure that it is as low risk as possible and achieves the desired outcomes.

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