FDA Approves Tryvio for the Combination Treatment of Resistant Hypertension
Idorsia Pharmaceuticals U.S. Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Tryvio™ (aprocitentan) for the treatment of hypertension in combination with other antihypertensive drugs, to lower blood pressure in adult patients who are not adequately controlled on other drugs. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. The recommended dosage of Tryvio is 12.5mg orally once daily, with or without food.
Tryvio (aprocitentan) is 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. Until the approval of Tryvio, no systemic antihypertensive medications targeted the ET pathway, as approved antihypertensive therapies focus on the regulation of salt and water (diuretics), antagonism of the renin–angiotensin–aldosterone (RAAS) system, reduction of influx of extracellular calcium into the cell (calcium channel blockers), sympatholytic activity (beta blockers, central alpha-agonist agents), or non-selective vasodilatory effects.
Tryvio is available only through a restricted program under a REMS called the Tryvio REMS because of the risk of embryo-fetal toxicity. Prescribers must be certified with the Tryvio REMS by enrolling and completing training. Pharmacies that dispense Tryvio must be certified with the Tryvio REMS.
