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PHSANZ News Bulletin
 

Uptravi® (selexipag) – Registration in Australia and New Zealand for PAH 

1 May 2016: Actelion Pharmaceuticals Australia Pty Ltd announced that the Therapeutic Goods Administration (TGA) of Australia and the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) have granted registration for the orally active selective IP prostacyclin receptor agonist Uptravi (selexipag) for the treatment of pulmonary arterial hypertension (PAH).  

The labels were based in part on the Phase III GRIPHON study, whose main findings were published in the New England Journal of Medicine in December 2015 3.  The safety of selexipag has been evaluated in a long-term, Phase III placebo-controlled study enrolling 1,156 patients with symptomatic PAH (GRIPHON study). The mean treatment duration was 76.4 weeks (median 70.7 weeks) for patients receiving selexipag versus 71.2 weeks (median 63.7 weeks) for patients on placebo. The exposure to selexipag was up to 4.2 years. In the study, treatment with selexipag resulted in a 40% relative risk reduction (hazard ratio 0.60; 99% CI, 0.46 to 0.78; logrank p < 0.0001) of the composite morbidity/mortality endpoint when compared to placebo. 

The most commonly reported adverse reactions related to the pharmacological effects of Uptravi are headache, diarrhoea, nausea and vomiting, jaw pain, myalgia, pain in extremity, arthralgia, and flushing. These reactions are more frequent during the up-titration phase. The majority of these reactions are of mild to moderate intensity. 

Full Uptravi Press Release
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