Actelion submits New Drug Application to the FDA for pulmonary arterial hypertension drug Uptravi

Swiss biotech company Actelion (SIX: ATLN) has submitted a New Drug Application to the US Food and Drug Administration seeking approval for its pulmonary arterial hypertension drug Uptravi (selexipag).

Uptravi is seen as a replacement for Actelion's mainstay PAH drug Tracleer (bosentan), which currently accounts for around 80% of the firm's sales, but loses patent protection next year. Analysts at Barclays estimate peak sales for the new drug at about 2 billion Swiss francs ($2.04 billion). Recently launched Opsumit (macitentan) also adds to the firm's PAH franchise, where Tracleer generated sales of 1.15 billion Swiss francs in the first nine months of this year.

Clinical backing

The selective oral IP prostacyclin receptor agonist was studied in the pivotal Phase III trial GRIPHON, in 1,156 patients with pulmonary arterial hypertension. Results reported in June 2014 showed selexipag decreased the risk of a morbidity/mortality event against placebo by 39%. Patients were treated for up to 4.2 years.