Idorsia's JERAYGO (aprocitentan) approved in Canada for the treatment of resistant hypertension

Core Viewpoint - Idorsia Ltd has received marketing authorization from Health Canada for JERAYGO™ (aprocitentan), the first and only endothelin receptor antagonist for treating resistant hypertension in adults [1][11]. Group 1: Product Information - JERAYGO™ is indicated for adult patients with resistant hypertension, defined as uncontrolled blood pressure despite the use of at least three antihypertensive medications from different classes [2][11]. - The recommended starting dose is 12.5 mg orally once daily, which can be increased to 25 mg for patients needing tighter blood pressure control [1]. - Aprocitentan is a dual endothelin receptor antagonist that inhibits the binding of ET-1 to ETA and ETB receptors, representing a new pathway in hypertension treatment [11]. Group 2: Clinical Study Insights - The efficacy of aprocitentan was evaluated in the Phase 3 PRECISION study, which included 730 patients with uncontrolled blood pressure [5][9]. - The primary endpoint was the change in sitting systolic blood pressure (SiSBP) from baseline to Week 4, showing significant reductions compared to placebo [6][9]. - A substantial proportion (at least 90%) of the blood pressure-lowering effect was observed within the first two weeks of treatment [9]. Group 3: Patient Demographics and Health Background - The mean age of patients in the study was 61.7 years, with 34.1% aged 65-74 years and 9.9% aged 75 years or older [7]. - A significant portion of patients had comorbidities, including type 2 diabetes (54.1%), ischemic heart disease (30.8%), and chronic kidney disease (22.2%) [8]. Group 4: Safety and Adverse Reactions - Common adverse reactions reported with aprocitentan included edema/fluid retention (9.1% for 12.5 mg and 18.4% for 25 mg) and decreased hemoglobin (3.7% for 12.5 mg and 1.2% for 25 mg) [10]. - JERAYGO is contraindicated in pregnant women, those breastfeeding, and patients with severe hepatic impairment or hypersensitivity to the active substance [10].