The US Food and Drug Administration (FDA) has approved Idorsia Ltd.’s 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.
 
Jean-Paul Clozel, MD and CEO of Idorsia commented, “Today, there are millions of Americans whose blood pressure is not well-controlled despite existing therapies. This is a major public health issue leading to a high incidence of cardio- and cerebrovascular events. In order to help address this issue, Idorsia developed aprocitentan, an endothelin receptor antagonist suited to the treatment of these patients. Idorsia conducted an ambitious clinical program in patients remaining hypertensive despite a minimum of three drugs at their optimal dose and sometimes up to four, five, or even six antihypertensives. I’m very proud of the Idorsia team and very happy that physicians will have a new treatment option to treat patients whose blood pressure is not controlled.”

About TRYVIO

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 was evaluated as a monotherapy in a Phase 2 study in patients with hypertension, and as an add-on therapy in a Phase 3 study called PRECISION in patients with confirmed resistant hypertension. In PRECISION, aprocitentan was well tolerated and superior to placebo in lowering blood pressure at week 4, with a sustained effect at week 40.
 
Martine Clozel, MD and Chief Scientific Officer of Idorsia, said: “We were delighted when we saw the safety and efficacy data with TRYVIO, even on top of multiple antihypertensives, in patients whose hypertension is not adequately controlled. The recognition of its potential with today’s FDA approval is great news for prescribers and patients.”

More Idorsia News

Global healthcare company Viatris Inc. and Idorsia Ltd recently entered a significant global research and development collaboration under which Viatris will receive exclusive global development and commercialization rights to two Phase 3 assets as well as the potential to add additional assets in the future.