CHMP positive for Jeraygo (aprocitentan) for the treatment of resistant hypertension in adult patients in combination with at least three antihypertensive medicinal products.- Idorsia Ltd.

The CHMP has adopted a positive opinion for the use of 12.5 mg Jereygo orally once daily. The dose can be increased to 25 mg once daily for patients tolerating the 12.5 mg dose and in need of tighter blood pressure (BP) control. expected in approximately two months.

Hypertension is one of the leading causes of cardiovascular disease worldwide, impacting an estimated 1.3 billion people globally. Approximately 10% of these people have uncontrolled BP, despite receiving at least three antihypertensive medications from different classes, at optimal doses and they are categorized in hypertension guidelines as having resistant hypertension. Compared with adults whose hypertension is well controlled, adults with uncontrolled hypertension have greater risk of heart attack, heart failure, stroke, end-stage renal disease and death.

Jean-Paul Clozel, MD and Chief Executive Officer of Idorsia commented: “Uncontrolled hypertension, particularly resistant hypertension, where blood pressure remains uncontrolled despite the use of multiple antihypertensive therapies, affects millions of Europeans and is a major public health issue leading to a high risk of heart attack, heart failure, stroke and renal disease, not to mention the increased risk of death. Idorsia has tackled this need by developing aprocitentan, or Jeraygo , the brand name in Europe, an endothelin receptor antagonist discovered by our team and optimized for the treatment of resistant hypertension. As a result of our efforts, physicians and patients in Europe are one step closer to having a new oral antihypertensive therapy – the first in almost 40 years – that is working via a new therapeutic pathway.”

The positive CHMP opinion is supported by a comprehensive clinical and non-clinical development program. Aprocitentan 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 the Phase III registration study, PRECISION, aprocitentan showed statistically significant and clinically meaningful reduction in blood pressure (BP) which was maintained for up to 48 weeks when added to a combination of background antihypertensive therapies in patients with resistant hypertension. In PRECISION, aprocitentan was generally well tolerated with no major safety concerns. The most frequent adverse event with aprocitentan was mild-to-moderate edema/fluid retention.