FDA approval represents ‘transformational progress’ in hypertension

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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 other drugs.

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.

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. 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.”

30 years in the making

Tryvio was evaluated as a monotherapy in a Phase II study in patients with hypertension, and as an add-on therapy in a Phase III 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 four, with a sustained effect at week 40.

Michael Weber, Professor of Medicine, Division of Cardiovascular Medicine, State University of New York, and an investigator in the PRECISION study, commented: “Today, we are not able to reduce blood pressure below recommended levels in at least 10% of the hypertensive patients we treat. We have had to wait for over 30 years to see the approval of an oral anti-hypertensive agent that works on a new therapeutic pathway, so Tryvio provides transformational progress in the field of systemic hypertension.”

Martine Clozel, MD and Chief Scientific Officer of Idorsia, concluded: “After more than 30 years working in the field of endothelin science, our research has brought about changes in the treatment paradigm of several cardiovascular diseases. Now we are bringing significant medical progress for patients with systemic hypertension. I am convinced that with the data we have seen, the approval of Tryvio heralds a new era of endothelin research beyond hypertension, where we intend to investigate the utility of aprocitentan for first-in-class applications in new indications.”

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