FDA approves dual endothelin A and B receptor antagonist for uncontrolled hypertension
25/03/2024
The FDA approved aprocitentan, a dual endothelin A and B receptor antagonist, for the treatment of high blood pressure (BP) not adequately controlled in combination with other antihypertensive drugs.
This decision was based on the results from the phase 3 PRECISION trial, in which aprocitentan was evaluated as an add-on therapy in patients with resistant hypertension. In the PRECISION trial, treatment with aprocitentan was superior to placebo in lowering BP at week 4, and the BP-lowering effect was sustained at week 40.
The approval marks the occurrence of the first oral antihypertensive therapy that targets a new mechanism in almost 40 years. Aprocitentan targets the endothelin (ET) pathway by inhibiting the binding of ET-1 to the ETA and ETB receptors. ET-1 plays a key role in the pathophysiology of hypertension, and is a major driver of aldosterone production.