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Selexipag meets primary efficacy endpoint for PAH in phase 3 study

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Selexipag met the primary endpoint of reduced risk for morbidity and mortality compared with placebo in a phase 3 trial of patients with pulmonary arterial hypertension, according to a new press release.

The multicenter, double blind GRIPHON study assessed the oral prostacyclin IP receptor agonist selexipag (Actelion) vs. placebo in 1,156 patients with PAH enrolled at 181 facilities in 39 countries. Patients were assigned twice-daily selexipag 200 mcg, with gradual increases of 200 mcg to a maximum maintenance dose of 1,600 mcg twice daily, for up to 4.3 years.

“[The] GRIPHON results represent a major step forward,” Gérald Simonneau, MD, professor of pulmonology and head of the department of pulmonary disease at Université Paris-Sud, Le Kremlin-Bicêtre, France, stated in the release. “For the first time, with selexipag, we have an oral compound acting on the prostacyclin pathway showing a significant risk reduction on a highly clinically relevant endpoint.”

Risk for morbidity or mortality was reduced by 39% among selexipag recipients compared with placebo recipients (P<.0001). This effect was observed regardless of age, sex, WHO functional class, PAH etiology or background therapy, according to the release.

Tolerability was similar to that observed with other prostacyclin therapies, according to the release. Patients discontinued treatment due to adverse events in 14% of cases in the selexipag group vs. 7% in the placebo group. Headache, diarrhea, nausea, vomiting, jaw and extremity pain, myalgia, flushing and nasopharyngitis were more commonly reported in the selexipag group, according to the release.

“The GRIPHON study results hold the promise that selexipag might open up the prostacyclin pathway to different groups of patients, given the consistent efficacy findings across key subgroups,” Vallerie McLaughlin, MD, director of the pulmonary hypertension program in the cardiovascular medicine division at University of Michigan, said in the release. “In addition, GRIPHON has shown once again that registration studies that follow the robust morbidity/mortality definitions … have the potential to deliver truly meaningful clinical information.”