The Food and Drug Administration (FDA) has approved Uptravi (selexipag; Actelion) tablets for the treatment of adults with pulmonary arterial hypertension (PAH) to delay disease progression and reduce the risk of hospitalization for PAH.
The FDA approval was based on data from the long-term Phase 3 GRIPHON study (n=1,156) of patients with symptomatic PAH. Treatment with Uptravi was effective in reducing hospitalization for PAH and reducing the risk of disease progression vs. placebo. The risk of primary composite endpoint was reduced by 40% (P<0.0001) when treated with Uptravi vs. placebo. Patients were treated up to 4.2 years with a median duration of exposure of 1.4 years.
Uptravi is a selective oral IP prostacylin receptor agonist. Prostacyclin activates the IP receptor to induce vasodilation and inhibit proliferation of vascular smooth muscle cells.
Uptravi was granted orphan drug designation by the FDA. It is expected to launch in early January 2016.
For more information call (866) 344-4874 or visit Actelion.com.