Actelion receives Swissmedic approval for Uptravi (selexipag) for treatment of pulmonary arterial hypertension

Actelion Pharmaceuticals Ltd / Actelion receives Swissmedic approval for Uptravi (selexipag) for treatment of pulmonary arterial hypertension . Processed and transmitted by NASDAQ OMX Corporate Solutions. The issuer is solely responsible for the content of this announcement.

ALLSCHWIL/BASEL, SWITZERLAND - 16 August 2016 - Actelion Ltd (SIX: ATLN) announced today that Swissmedic has granted approval for the orally active, selective IP prostacyclin receptor agonist Uptravi^® (selexipag), originally discovered and synthesized by Nippon Shinyaku, for patients with PAH in Switzerland.

Uptravi is indicated for the treatment of pulmonary arterial hypertension (PAH) in patients with advanced functional limitation (NYHA-functional class III/IV) to delay disease progression.

Uptravi is effective in combination with an endothelin receptor antagonist (ERA) or a phosphodiesterase-5 (PDE-5) inhibitor, or in triple combination with an ERA and a PDE-5 inhibitor, or as monotherapy.

Jean-Paul Clozel, Chief Executive Officer of Actelion commented: "The Swissmedic approval represents a major milestone for PAH patients in Switzerland. As a new oral medication that effectively targets the prostacyclin pathway, Uptravi is supported by robust long-term outcome results in combination with an ERA, or a PDE-5 inhibitor, and, for the first time in PAH, in triple combination with both an ERA and a PDE-5 inhibitor. We are now working diligently to make Uptravi available to patients in Switzerland as soon as possible."

The Swissmedic approval for Uptravi was based 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 Uptravi in patients with PAH. [1]

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NOTES TO THE EDITOR  

REGULATORY STATUS OF SELEXIPAG 
Market authorization has so far been received in the US (21 December 2015), Canada (21 January 2016), New Zealand (17 March 2016), Australia (18 March 2016), South Korea (11 May 2016), the European Union (12 May 2016) and in Switzerland (15 August 2016). Submission of the registration dossier to other health authorities is ongoing, with regulatory reviews underway in Brazil, Israel, Japan, Singapore, Taiwan and Turkey.