Idorsia's JERAYGO approved in Europe for resistant hypertension

ALLSCHWIL, Switzerland I July 1, 2024 I Idorsia Ltd (SIX: IDIA) announced the European Commission's (EC) approval of JERAYGO™ (aprocitentan) for treating resistant hypertension in adults, to be used in combination with at least three antihypertensive drugs. The recommended starting dose is 12.5 mg taken orally once a day, with the possibility of increasing to 25 mg for patients who tolerate the initial dose and require more stringent blood pressure control.

Hypertension is a leading cause of cardiovascular disease globally, affecting around 1.3 billion people. Approximately 10% of these individuals have resistant hypertension, characterized by uncontrolled blood pressure despite treatment with multiple antihypertensive medications at optimal doses.

Prof. Krzysztof Narkiewicz, Head of the Department of Hypertension and Diabetology at the Medical University of Gdansk, Poland, remarked on the significance of JERAYGO. He highlighted that the drug targets the endothelin system, offering a new pathway for treatment. Clinical trials have demonstrated that JERAYGO provides a rapid and sustained reduction in blood pressure, particularly in patients with resistant hypertension. This group is at increased risk for severe health issues such as heart attack, heart failure, stroke, end-stage renal disease, and premature death due to their high blood pressure levels.

Alberto Gimona, Head of Global Clinical Development & Medical Affairs at Idorsia, underscored the importance of JERAYGO's approval, noting it as the first innovative antihypertensive drug in 40 years acting on the endothelin pathway. He emphasized the drug's consistent blood pressure-lowering effects across different measurement methods and patient subgroups, including those with chronic kidney disease. Additionally, JERAYGO showed a significant reduction in albuminuria, pointing to its potential benefits beyond blood pressure control.

André Muller, Chief Executive Officer of Idorsia, commented on the strategic importance of aprocitentan, describing it as a largely unencumbered asset approved in both the US and Europe. Idorsia is exploring various funding and collaboration opportunities to commercialize aprocitentan while preparing for its market introduction in these regions.

The approval of JERAYGO is based on results from the Phase 3 PRECISION study, which evaluated the efficacy of aprocitentan in patients with uncontrolled blood pressure despite using at least three antihypertensive drugs. The study involved a three-part design: initial double-blind treatment, single-blind treatment, and double-blind withdrawal. The primary efficacy endpoint was the change in sitting systolic blood pressure (SiSBP) from baseline to Week 4. Key secondary endpoints included changes in SiSBP during the withdrawal phase.

The study included 730 patients, who were divided into groups receiving aprocitentan 12.5 mg, aprocitentan 25 mg, or a placebo. Results showed significant blood pressure reductions with both doses of aprocitentan compared to placebo. The blood pressure-lowering effect was consistent across various demographic subgroups and remained stable over time. The study also noted a rapid onset of action, with most of the effect observed within the first two weeks of treatment.

Common adverse reactions included edema or fluid retention and decreased hemoglobin. JERAYGO is contraindicated for use in pregnant or breastfeeding women and those with severe hepatic impairment.

JERAYGO's approval marks a significant advancement in treating resistant hypertension, providing a new option for patients who have not achieved adequate blood pressure control with existing therapies.