- Marketing authorization granted by European Commission on 12 May 2016
- First European Union (EU) market introduction to commence in the near future
ALLSCHWIL, SWITZERLAND – 17 May 2016 – Actelion (SIX: ATLN) announced today that the European Commission has granted marketing authorization in the EU for the orally active, selective IP prostacyclin receptor agonist Uptravi® (selexipag) for the treatment of pulmonary arterial hypertension.
Uptravi is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients with WHO functional class (FC) II-III, either as combination therapy in patients insufficiently controlled with an endothelin receptor antagonist (ERA) and/or a phosphodiesterase type 5 (PDE-5) inhibitor, or as monotherapy in patients who are not candidates for these therapies. Efficacy has been shown in a PAH population including idiopathic and heritable PAH, PAH associated with connective tissue disorders, and PAH associated with corrected simple congenital heart disease.
The EU label for Uptravi (originally discovered and synthesized by Nippon Shinyaku) was based in part on the Phase III GRIPHON study, whose main findings were published in the New England Journal of Medicine in December 2015.
Professor Sean Gaine, Consultant Respiratory Physician at Mater Misericordiae Hospital Dublin, commented: “For many years we have known that the prostacyclin pathway can be key in treating PAH – yet due to the route of administration of the existing therapies being so burdensome, the pathway has been largely underused, with only about 20% of patients ever receiving a prostacyclin at some point during their PAH treatment. Uptravi, as an innovative oral treatment that is supported by long-term outcome results, now allows us to offer combination therapy regimens that target all three established treatment pathways.”
Professor Nazzareno Galiè, Head of the Pulmonary Hypertension Center at the Institute of Cardiology, University of Bologna, added: “The approval of Uptravi is very positive news for the PAH community in Europe. With Uptravi, for the first time ever, we see a significant clinical benefit in combination with one and even two drugs targeting other treatment pathways. Together with its favorable tolerability profile, this makes Uptravi a treatment option that could truly change PAH care, for many patients.”
The safety of selexipag has been evaluated in a long-term, Phase III placebo controlled study enrolling 1,156 patients with symptomatic PAH. 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.
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.