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][12]. Company Overview - Idorsia is focused on developing transformative medicines and aims to evolve into a leading biopharmaceutical company with a strong scientific core [15][17]. - The company has a promising in-house development pipeline and is engaged in discussions to maximize the availability of JERAYGO to patients [4][12]. Product Details - JERAYGO is indicated for adult patients with resistant hypertension, defined as uncontrolled blood pressure despite the use of at least three antihypertensive medications [1][3]. - 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]. Clinical Study Insights - The efficacy of aprocitentan was evaluated in the Phase 3 PRECISION study, which included 730 patients with uncontrolled blood pressure [6][10]. - The primary efficacy endpoint was the change in sitting systolic blood pressure (SiSBP) from baseline to Week 4, showing significant reductions compared to placebo [7][10]. - A substantial proportion of the blood pressure-lowering effect was observed within the first two weeks of treatment [10]. Patient Demographics - 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 [8]. - A significant portion of patients had comorbidities, including type 2 diabetes (54.1%) and chronic kidney disease (22.2%) [9]. Safety Profile - Common adverse reactions included edema/fluid retention and decreased hemoglobin levels [11]. - JERAYGO is contraindicated in specific populations, including pregnant women and those with severe hepatic impairment [11].