Actelion has submitted a New Drug Application US regulators seeking approval for its hypertension drug Uptravi (selexipag).

The filing is backed by Phase III data showing that the drug - the first selective oral IP prostacyclin receptor agonist - decreased the risk of a morbidity/mortality event versus placebo by 39% in patients with pulmonary arterial hypertension (PAH).

Efficacy observed was consistent across the key subgroups; age, gender, WHO Functional Class, PAH etiology and background PAH therapy, the Swiss biotech noted, adding that the overall tolerability profile of the Uptravi “was consistent with prostacyclin therapies”. 

The move comes hot on the heels of a submission in Europe earlier this month, and analysts predict that, if the drug makes it to market, it will attain blockbuster status and help offset declining sales of Tracleer, which goes off-patent next year.