CHMP Backs Selexipag for Pulmonary Arterial Hypertension

Miriam E. Tucker


January 29, 2016

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the marketing of selexipag (Uptravi, Actelion Registration Ltd) for the treatment of adults with pulmonary arterial hypertension (PAH).

The full indication is "for the long-term treatment of [PAH] in adult patients with World Health Organization functional class II–III, either as combination therapy in patients insufficiently controlled with an endothelin receptor antagonist and/or a phosphodiesterase type 5 inhibitor, or as monotherapy in patients who are not candidates for these therapies."

Selexipag is an orally available, selective prostacyclin receptor agonist that is distinct from prostacyclin and its analogues. By activating the prostacyclin receptor, the agent leads to vasodilatation and inhibition of platelet aggregation. In patients with PAH, it dilates the pulmonary arteries and also has antiproliferative and antifibrotic effects, which decrease pulmonary arterial pressure and delay disease progression.

The drug will be available in doses of 200, 400, 600, 800, 1000, 1200, 1400, and 1600 μg film-coated tablets. Patients should be started at 200 μg given twice daily and up-titrated to the highest individually tolerated dose to a maximum of 1600 μg twice daily.

The most common adverse effects are headache, diarrhea, nausea and vomiting, jaw pain, myalgia, pain in extremity, arthralgia, and flushing. These reactions are more frequent during the up-titration phase, and are mostly of mild to moderate intensity.

Selexipag was first designated as an orphan medicinal product in August 2005.


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