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].

Core Insights - Idorsia Ltd has received marketing authorization from Swissmedic for JERAYGO (aprocitentan) to treat resistant hypertension in adults, marking it as the first and only endothelin receptor antagonist for this condition [1][8] - Resistant hypertension affects approximately 10% of hypertensive patients, highlighting the need for more effective treatment options [3] - JERAYGO has shown significant blood pressure reduction in diverse patient populations, including those with obesity, chronic kidney disease, or type 2 diabetes [4] Company Overview - Idorsia is focused on developing transformative medicines and has a strong scientific foundation, with JERAYGO representing their second product approval in Switzerland [4][15] - The company is in discussions with potential partners to expand the availability of JERAYGO across Switzerland and Europe [4] Product Details - JERAYGO is administered orally at a recommended starting dose of 12.5 mg once daily, which can be increased to 25 mg for patients needing tighter blood pressure control [1] - Aprocitentan, the active ingredient in JERAYGO, is a dual endothelin receptor antagonist that has been commercially available in the US as TRYVIO™ since October 2024 [12] Clinical Study Findings - The Phase 3 PRECISION study demonstrated that both 12.5 mg and 25 mg doses of aprocitentan significantly reduced sitting systolic blood pressure compared to placebo [10] - The treatment effect was consistent across various demographics, including age, sex, and race, and was evident within the first two weeks of treatment [10] Patient Demographics - The study included 730 patients with a mean age of 61.7 years, with a significant portion having comorbidities such as type 2 diabetes (54.1%) and chronic kidney disease (22.2%) [7][9] Safety Profile - Common adverse reactions to aprocitentan included edema/fluid retention and decreased hemoglobin levels, with specific contraindications for pregnant women and those with severe hepatic impairment [11]