FDA approves Idorsia’s Tryvio for treatment of high blood pressure
Betsy Goodfellow | March 22, 2024 | News story | Medical Communications | Cardiology, FDA, Tryvio, blood pressure, blood presure, hypertension
Idorsia has announced that the US 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 prior treatments.
The drug is an ‘endothelin receptor antagonist that inhibits the binding of endothelin (ET)-1 to ETA and ETB receptors’, according to the company’s press release.
Tryvio has been assessed as a monotherapy in a phase 2 study in patients with hypertension and as an add-on therapy in the phase 3 PRECISION study in adults with confirmed resistant hypertension.
The drug was well tolerated and superior to placebo in lowering blood pressure by week 4 of the PRECISION study, with a sustained impact at week 40.
Jean-Paul Clozel, MD and chief executive officer 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 programme 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.”
Betsy Goodfellow
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