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- Veletri receives TGA approval
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Media Release 

Actelion Pharmaceuticals Australia Pty Ltd receives Therapeutic Goods Administration (TGA) approval of Veletri® (epoprostenol powder for injection) for the treatment of pulmonary arterial hypertension1. 

Belrose, Australia – 6 MARCH 2014. 

Actelion Pharmaceuticals Australia Pty Ltd announced today approval by the TGA of Veletri® for the treatment of pulmonary arterial hypertension (PAH). 

Veletri® is indicated for the long-term treatment, via continuous intravenous infusion, in WHO functional class III or IV patients with idiopathic or familial PAH, and PAH associated with the scleroderma spectrum of diseases. 

Veletri® is available in two strengths; 0.5 mg and 1.5 mg vials, and can be reconstituted with sodium chloride 0.9% solution for injection or sterile water for injection. 

The formulation of Veletri® has been developed to prolong stability once reconstituted. Veletri® offers two preparation and storage options for patients: 

1 – Prepare and use immediately1: Fully diluted Veletri® can be administered for up to 48 hours at room temperature (25◦C) at concentrations ≥ 3000 ng/mL. 

2 – Prepare and store for up to 8 days in refrigerator before use1: Fully diluted Veletri® can be stored in the refrigerator (i.e. 2◦C to 8◦C) for up to 8 days and then administered at room temperature (25◦C) for up to 24 hours at concentrations between 3000 ng/mL and 15000 ng/mL and up to 48 hours at concentrations ≥ 15000 ng/mL. 

Dr Helen Whitford, Respiratory Physician, Department of Allergy Immunology & Respiratory Medicine, Lung Transplantation Service, The Alfred, Melbourne, commented: 

“PAH is a devastating disease whose effects extend far beyond the physical symptoms. The physical, emotional and social burden of PAH increases significantly as the disease worsens. We cannot underestimate the burden that patients face when their PAH worsens. Anything that can make their lives simpler and easier is to be welcomed. Veletri is an innovative formulation that can be infused at room temperature, removing the need for patients to carry ice packs. I am optimistic that this new treatment will allow us to improve the quality of life for patients with late stage PAH.” 

Should you have any questions or require additional information, please contact Actelion Australia Medical Information on 02 9486 4600. 

Media release
Veletri Consumer Medical Information
Veletri Product Information


Pulmonary arterial hypertension (PAH) is a chronic, life-threatening disorder characterised by abnormally high blood pressure in the arteries between the heart and lungs of an affected individual. The symptoms of PAH are non-specific and can range from mild breathlessness and fatigue during normal daily activity to symptoms of right heart failure and severe restrictions on exercise capacity and ultimately reduced life expectancy. 

PAH is one group within the classification of pulmonary hypertension (PH). This group includes idiopathic PAH, heritable PAH and PAH caused by factors which include connective tissue disease, HIV infection and congenital heart disease. 

The last decade has seen significant advances in the understanding of the pathophysiology of PAH, which has been paralleled with developments of treatment guidelines and new therapies. Drugs targeting the 3 pathways that have been established in the pathogenesis of PAH are endothelin receptor antagonists (ERAs), prostacyclins and phosphodiesterase-5 inhibitors. PAH treatments have transformed the prognosis for PAH patients from symptomatic improvements in exercise tolerance 10 years ago to delayed disease progression today. Improved disease awareness and evidence-based guidelines developed from randomised controlled clinical trial data have highlighted the need for early intervention, goal-oriented treatment and combination therapy. 

Despite these advances in PAH, survival rates are unacceptably low and PAH remains incurable. 

Actelion Ltd. 

Actelion Ltd is a biopharmaceutical company with its corporate headquarters in Allschwil/Basel, Switzerland. Actelion's first drug Tracleer®, an orally available dual endothelin receptor antagonist, has been approved as a therapy for pulmonary arterial hypertension. Actelion markets Tracleer® through its own subsidiaries in key markets worldwide, including the United States (based in South San Francisco), the European Union, Japan, Canada, Australia and Switzerland. Actelion, founded in late 1997, is a leading player in innovative science related to the endothelium - the single layer of cells separating every blood vessel from the blood stream. Actelion's over 2,400 employees focus on the discovery, development and marketing of innovative drugs for significant unmet medical needs. 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®). 


1. VELETRI Approved Product Information TGA Registered 28 February 2014 

2. Proceedings of the 4th world symposium on pulmonary hypertension. J Am CollCardiol 2009;54(1 Suppl). 

3. Galiè N, Hoeper MM, Humbert M, et al; ESC Committee for Practice Guidelines (CPG). Guidelines for the diagnosis and treatment of pulmonary hypertension: the Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS), endorsed by the International Society of Heart and Lung Transplantation (ISHLT). Eur Heart J 2009;30:2493-537. 

4. Benza RL, Miller DP, Barst RJ, Badesch DB, Frost AE, McGoon MD. An evaluation of long-term survival from time of diagnosis in pulmonary arterial hypertension from REVEAL. Chest 2012;142:448-56. 

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