US regulators have agreed to review Actelion’s submission for new pulmonary arterial hypertension drug Uptravi (selexipag) within a standard timeframe.
The New Drug Application was filed with the US Food and Drug Administration on December 22, and Actelion is expecting the review process to take 12 months from this date.
The submission for Uptravi, the first selective oral prostacyclin IP receptor agonist, is based on the findings of the Phase III GRIPHON study, which showed that the drug decreased the risk of a morbidity/mortality event versus placebo by 40% with efficacy consistent across different subgroups (gender, age, etc).
In PAH, survival rates are unacceptably low and the condition remains incurable. “With selexipag, PAH specialists may be able to target the prostacyclin pathway with an oral therapy with long-term outcome benefits,” Actelion chief Jean-Paul Clozel has previously noted.