Actelion announced the commercial availability of the oral, selective, IP prostacyclin receptor agonist, Uptravi® (selexipag) for the treatment of pulmonary arterial hypertension (PAH) in Germany.
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 mono therapy 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. [1]
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. This placebo-controlled study, the largest ever in PAH, established the effectiveness, safety and tolerability of selexipag in PAH patients with WHO Functional Class II-III, showing that selexipag was able to reduce the risk of a morbidity/mortality event by 40%. [2]
Professor H. Ardeschir Ghofrani, University Hospital Giessen, Germany, commented: “Uptravi offers an oral therapy that effectively targets the prostacyclin pathway and significantly delays the progression of pulmonary arterial hypertension. It is supported by robust outcome-based evidence in combination with an ERA, or a PDE-5 inhibitor, and even in combination with both an ERA and a PDE-5 inhibitor. This opens the way for more oral combination treatments early on in the progression of the disease, with proven long-term outcome benefits for more patients.”
Michael Danzl, General Manager of Actelion Germany, commented: “The availability of Uptravi is a milestone for PAH patients in Germany, where until now, the options for treatments targeting the prostacyclin pathway have been limited, and were burdensome for the patients. With Uptravi, there is now an oral option in all three established treatment pathways.”
Hans Dieter Kulla, President of pulmonale hypertonie e.v., added: “This new product launch is a major step in terms of achieving the best possible care for patients living with PAH in Germany. We hope Uptravi can further impact the long-term outcome for many patients, which ultimately also helps their families and caregivers.”
The safety of Uptravi has been evaluated in a long-term, placebo-controlled study enrolling 1,156 patients with symptomatic PAH (GRIPHON study). The exposure to Uptravi in this trial was up to 4.2 years with median duration of exposure of 1.4 years. Adverse reactions occurring more frequently on Uptravi compared to placebo – greater than or equal to 3% – over the course of the study, were headache, diarrhea, jaw pain, nausea, myalgia, vomiting, pain in extremity, flushing, arthralgia, anemia, decreased appetite and rash. These adverse reactions are more frequent during the dose titration phase. Hyperthyroidism was observed in 1% (n=8) of patients on Uptravi and in none of the patients on placebo.
Uptravi is available in the following strengths: 200 mcg [Light yellow tablet debossed with 2], 400 mcg [Red tablet debossed with 4], 600 mcg [Light violet tablet debossed with 6], 800 mcg [Green tablet debossed with 8], 1000 mcg [Orange tablet debossed with 10], 1200 mcg [Dark violet tablet debossed with 12], 1400 mcg [Dark yellow tablet debossed with 14], 1600 mcg [Brown tablet debossed with 16]. Full prescribing information for healthcare professionals can be found on www.actelion.com
ACTELION LTD
Actelion Ltd. is a leading biopharmaceutical company focused on the discovery, development and commercialization of innovative drugs for diseases with significant unmet medical needs.
Actelion is a leader in the field of pulmonary arterial hypertension (PAH). Our portfolio of PAH treatments covers the spectrum of disease, from WHO Functional Class (FC) II through to FC IV, with oral, inhaled and intravenous medications. Although not available in all countries, Actelion has treatments approved by health authorities for a number of specialist diseases including Type 1 Gaucher disease, Niemann-Pick type C disease, Digital Ulcers in patients suffering from systemic sclerosis, and mycosis fungoides type cutaneous T-cell lymphoma.
Founded in late 1997, with now over 2,400 dedicated professionals covering all key markets around the world including Europe, the US, Japan, China, Russia and Mexico, Actelion has its corporate headquarters in Allschwil / Basel, Switzerland.
Actelion shares are traded on the SIX Swiss Exchange (ticker symbol: ATLN) as part of the Swiss blue-chip index SMI (Swiss Market Index SMI®). All trademarks are legally protected.
For further information please contact:
Andrew C. Weiss
Senior VP , Head of Investor Relations & Corporate Communications
Actelion Pharmaceuticals Ltd, Gewerbestrasse 16, CH-4123 Allschwil
+41 61 565 62 62
www.actelion.com
