Action required: Please refresh your browser
We have recently implemented some changes that require a hard refresh of your browser: Please hold down the CTRL-key and press the F5 key.
After a successful hard refresh, this message should not appear anymore.
More details about this topic are available here »
JERAYGO (aprocitentan) recommended for approval in Europe for the treatment of resistant hypertension | ||
By: GlobeNewswire - 26 Apr 2024 | Back to overview list |
|
Ad hoc announcement pursuant to Art. 53 LR
Allschwil, Switzerland – April 26, 2024 Detailed recommendations for the use of JERAYGO will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorization has been granted by the European Commission, expected in approximately two months. Hypertension is one of the leading causes of cardiovascular disease worldwide, impacting an estimated 1.3 billion people globally.1 Approximately 10% of these people have uncontrolled BP, despite receiving at least three antihypertensive medications from different classes, at optimal doses and they are categorized in hypertension guidelines2,3 as having resistant hypertension. Compared with adults whose hypertension is well controlled, adults with uncontrolled hypertension have greater risk of heart attack, heart failure, stroke, end-stage renal disease and death.4 Jean-Paul Clozel, MD and Chief Executive Officer of Idorsia commented: The positive CHMP opinion is supported by a comprehensive clinical and non-clinical development program. Aprocitentan was evaluated as a monotherapy in a Phase 2 study in patients with hypertension,11 and as an add-on therapy in a Phase 3 study called PRECISION in patients with confirmed resistant hypertension.12 In the Phase 3 registration study, PRECISION, aprocitentan showed statistically significant and clinically meaningful reduction in blood pressure (BP) which was maintained for up to 48 weeks when added to a combination of background antihypertensive therapies in patients with resistant hypertension. In PRECISION, aprocitentan was generally well tolerated with no major safety concerns. The most frequent adverse event with aprocitentan was mild-to-moderate edema/fluid retention. The team at Idorsia has been working on the research and development of endothelin receptor antagonists for more than 30 years, successfully bringing three other molecules from this class to patients in different indications. Endothelin (ET)-1, via its receptors (ETA and ETB), mediates a variety of effects such as vasoconstriction, fibrosis, cell proliferation, inflammation, aldosterone production7 and is upregulated in hypertension. Aprocitentan is a dual ERA that inhibits the binding of ET-1 to ETA and ETB receptors and hence the effects mediated by these receptors.5 The effects of ET-1 bear many similarities with the pathophysiology of hypertension,6,8 and the resistance to other antihypertensive drugs in some patients (often with risk factors such as obesity, sleep apnea, older age, kidney failure, type 2 diabetes, and African Americans), can be explained by an endothelin-dependent hypertension8. This is now confirmed by the efficacy of aprocitentan in the PRECISION study. About the Phase 3 PRECISION study (NCT03541174)12 At baseline, 69.2% of patients were obese or severely obese, 54.1% had diabetes, 22.2% had stage 3-4 chronic kidney disease and 19.6% had congestive heart failure. At screening, 63% of all patients who were randomly assigned were prescribed four or more antihypertensive drugs. Key PRECISION findings13 The results from ambulatory BP monitoring confirmed those derived from office measurements. At the end of Part 1, aprocitentan, after placebo correction, decreased both the 24-hour ambulatory SBP (–4.2 mmHg for the 12.5 mg dose and –5.9 mmHg for the 25 mg dose) and DBP (–4.3 mmHg for the 12.5 mg dose and –5.8 mmHg for the 25 mg dose). The placebo-corrected SBP lowering effect was The effect of aprocitentan was consistent across subgroups of age (including patients ? 75 years), sex, race (including patients with Black or African American origin), BMI, baseline urine albumin-to-creatinine ratio (UACR), baseline estimated Glomerular Filtration Rate (eGFR) and medical history of diabetes, and was consistent with the effect in the overall population. Treatment-emergent adverse events (TEAEs) during the 4-week double-blind study period (Part 1) were reported in 27.6% and 36.7% of the patients treated with 12.5 and 25 mg aprocitentan, respectively, versus 19.4% in the placebo group. The most frequent adverse event with aprocitentan was mild-to-moderate edema/fluid retention leading to discontinuation in seven patients during the study. Edema/fluid retention was reported more frequently with aprocitentan than with placebo in a dose-dependent fashion (9.1%, 18.4%, and 2.1% for patients receiving aprocitentan 12.5 mg, 25 mg and placebo, during Part 1, respectively; 18.2% for patients receiving aprocitentan 25 mg during Part 2; and 2.6% and 1.3% for patients on aprocitentan 25 mg and placebo, during Part 3, respectively). Regulatory status of aprocitentan In March, TRYVIO™ (aprocitentan) was approved by the US Food and Drug Administration (FDA). Notes to the editor References
About Idorsia Headquartered near Basel, Switzerland – a European biotech-hub – Idorsia is specialized in the discovery, development and commercialization of small molecules to transform the horizon of therapeutic options. Idorsia has a 25-year heritage of drug discovery, a broad portfolio of innovative drugs in the pipeline, an experienced team of professionals covering all disciplines from bench to bedside, and commercial operations in Europe and North America – the ideal constellation for bringing innovative medicines to patients. Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 750 highly qualified specialists dedicated to realizing our ambitious targets. For further information, please contact The above information contains certain "forward-looking statements", relating to the company's business, which can be identified by the use of forward-looking terminology such as "estimates", "believes", "expects", "may", "are expected to", "will", "will continue", "should", "would be", "seeks", "pending" or "anticipates" or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of the company's investment and research and development programs and anticipated expenditures in connection therewith, descriptions of new products expected to be introduced by the company and anticipated customer demand for such products and products in the company's existing portfolio. Such statements reflect the current views of the company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Attachment |
||
|
||
Copyright 2024 GlobeNewswire | Back to overview list |