FDA OKs Tryvio as Add-on for Hypertension

FDA has approved an Idorsia NDA for Tryvio (aprocitentan) for treating hypertension in combination with other antihypertensive drugs in adult patients who are not adequately controlled on other drugs. Aprocitentan is described as an endothelin receptor antagonist that inhibits the binding of endothelin (ET)-1 to ETA and ETB receptors. “The effects of ET-1 bear many similarities with the pathophysiology of hypertension, and ET-1 is a major driver of aldosterone production,” the company says.

Approval was based on data from a Phase 2 study where Tryvio was evaluated as a monotherapy in patients with hypertension, and as an add-on therapy in a Phase 3 study called PRECISION in patients with confirmed resistant hypertension, according to the company. “In PRECISION, aprocitentan was well tolerated and superior to placebo in lowering blood pressure at Week 4, with a sustained effect at Week 40,” it says.