JERAYGO (aprocitentan) recommended for approval in Europe for the treatment of resistant hypertension

Ad hoc announcement pursuant to Art. 53 LR

• Idorsia receives a positive opinion from the Committee for Medicinal Products for Human Use for JERAYGO (aprocitentan) as the first and only endothelin receptor antagonist for the treatment of resistant hypertension in adult patients in combination with at least three antihypertensive medicinal products.
• A CHMP positive opinion is one of the final steps before marketing authorization can be granted by the European Commission – a final decision is expected in approximately two months.

Allschwil, Switzerland – April 26, 2024
Idorsia Ltd (SIX: IDIA) announced today that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), adopted a positive opinion for the use of JERAYGO (aprocitentan) for the treatment of resistant hypertension in adult patients in combination with at least three antihypertensive medicinal products. The CHMP has adopted a positive opinion for the use of 12.5 mg JERAYGO 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.

Detailed recommendations for the use of JERAYGO will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorization has been granted by the European Commission, expected in approximately two months.

Hypertension is one of the leading causes of cardiovascular disease worldwide, impacting an estimated 1.3 billion people globally.¹ 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^2,3 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.⁴

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.”