Actelion's New Drug Application for selexipag (Uptravi) is accepted by the US FDA with a standard review time

Actelion Pharmaceuticals Ltd / Actelion's New Drug Application for selexipag (Uptravi) is accepted by the US FDA with a standard review time . Processed and transmitted by NASDAQ OMX Corporate Solutions. The issuer is solely responsible for the content of this announcement.

ALLSCHWIL, SWITZERLAND - 03 March 2015 - Actelion Ltd (SIX: ATLN) today announced the formal acceptance of the New Drug Application (NDA) for selexipag (Uptravi^®) by the US Food and Drug Administration (FDA).

The NDA dossier for selexipag (Uptravi) in the treatment of pulmonary arterial hypertension (PAH) was submitted to the FDA on the 22^rd December 2014. Actelion expects results from the review process 12 months from the date of NDA submission.

The FDA application for selexipag (Uptravi), the first selective oral prostacyclin IP receptor agonist, is based on the findings of the positive pivotal Phase III GRIPHON study in 1,156 patients with pulmonary arterial hypertension (PAH).

The GRIPHON study demonstrated that selexipag decreased the risk of a morbidity/mortality event versus placebo by 40% (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 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: "The acceptance of the Uptravi dossier by the FDA is great news, our team has put considerable efforts into delivering a high quality dossier and this takes us one step closer to offering a new treatment option to the PAH community. I am looking forward to sharing our deep understanding of the data with health authorities throughout 2015 and also with the broader scientific community, starting with the first presentation at ACC in March."

The first scientific presentation of the data will take place at the 2015 American College of Cardiology congress (ACC.15) on Sunday March 15th in San Diego, California.

 

 

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Notes to Editor:

 

REGULATORY STATUS OF SELEXIPAG

In December 2014, Actelion submitted the registration dossier for selexipag to both Europe's EMA and the US FDA for the treatment of patients with pulmonary arterial hypertension. Submission of the registration dossier to other Health Authorities is ongoing with regulatory review underway in New Zealand, Switzerland and Canada.