Actelion submits US FDA New Drug Application for selexipag (Uptravi) in patients with pulmonary arterial hypertension

Actelion Pharmaceuticals Ltd / Actelion submits US FDA New Drug Application for selexipag (Uptravi) in patients with pulmonary arterial hypertension . Processed and transmitted by NASDAQ OMX Corporate Solutions. The issuer is solely responsible for the content of this announcement.

ALLSCHWIL, SWITZERLAND - 23 December 2014 - Actelion Ltd (SIX: ATLN) today announced that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval for selexipag (Uptravi^®) for the treatment of patients with pulmonary arterial hypertension (PAH).

Selexipag, the first selective oral IP prostacyclin receptor agonist, was studied in the pivotal Phase III GRIPHON study in 1,156 patients with pulmonary arterial hypertension (PAH). As reported in June 2014, the study demonstrated that selexipag decreased the risk of a morbidity/mortality event versus placebo by 39% (p<0.0001). Efficacy observed was consistent across the key subgroups; age, gender, WHO Functional Class, PAH etiology and background PAH therapy. Patients were treated for up to 4.2 years. The overall tolerability profile of selexipag in GRIPHON was consistent with prostacyclin therapies. Adverse reactions occurring more frequently (>5%) on selexipag compared to placebo are headache, diarrhea, jaw pain, nausea, myalgia, vomiting, pain in extremity, and flushing.

Jean-Paul Clozel, M.D. and Chief Executive Officer of Actelion commented: "Successfully submitting the selexipag NDA dossier to the FDA is another great milestone for us at Actelion, and a great way to mark the end of a remarkable year for us all. With the submission process underway for selexipag with both the FDA and EMA, I am looking forward to 2015 and to continuing to work with health authorities to move forward with these submissions in order to make selexipag available to the PAH community at the earliest opportunity."

 

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Notes to Editor:

PULMONARY ARTERIAL HYPERTENSION (PAH)

Pulmonary arterial hypertension (PAH) is a chronic, life-threatening disorder characterized 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 three pathways that have been established in the pathogenesis of PAH are endothelin receptor antagonists (ERAs), prostacyclin analogs 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 randomized controlled clinical trial data have highlighted the need for early intervention, goal-oriented treatment and combination therapy.