Core Viewpoint - Idorsia Ltd has received marketing authorization from Swissmedic for JERAYGO™ (aprocitentan), a treatment for resistant hypertension in adults, marking a significant advancement in hypertension therapy [1][7]. Group 1: Product Information - JERAYGO™ is the first and only endothelin receptor antagonist (ERA) approved for resistant hypertension, targeting a previously unaddressed pathway in hypertension treatment [7]. - The recommended starting dose of JERAYGO is 12.5 mg once daily, which can be increased to 25 mg for patients needing tighter blood pressure control [1]. - Aprocitentan has shown rapid and durable double-digit blood pressure reductions across diverse patient populations, including those with obesity, chronic kidney disease, or type 2 diabetes [3]. Group 2: Clinical Study Insights - The efficacy of aprocitentan was evaluated in a Phase 3 multicenter study involving 730 patients with uncontrolled blood pressure despite treatment with at least three antihypertensive medications [5][6]. - The primary efficacy endpoint was the change in sitting systolic blood pressure (SiSBP) from baseline to Week 4, with significant reductions observed in both SiSBP and sitting diastolic blood pressure (SiDBP) compared to placebo [9]. - A substantial proportion (at least 90%) of the blood pressure-lowering effect was noted within the first two weeks of treatment [9]. Group 3: Patient Demographics and Safety - The study population had a mean age of 61.7 years, with 34.1% aged 65-74 years and 9.9% aged 75 years or older; 59.5% were male [6]. - Common adverse reactions included edema/fluid retention and decreased hemoglobin levels, with specific contraindications for pregnant women and those with severe hepatic impairment [10]. Group 4: Market Context - Approximately 10% of hypertensive patients are classified as having resistant hypertension, highlighting the urgent need for effective therapies [2]. - Aprocitentan is already approved in the US as TRYVIO™ for systemic hypertension and is under review in Canada, indicating a growing market presence [11].
Idorsia's JERAYGO (aprocitentan) approved in Switzerland for the treatment of resistant hypertension
Globenewswire·2025-09-19 05:00