Edarbi® (Azilsartan Medoxomil Potassium Tablets) Approved in China for the Treatment of Essential Hypertension in Adults

Shanghai, January 20, 2021 /PRNewswire/ -- Today, Takeda China announced the new generation of angiotensinIIAngiotensin II Receptor Blockers (ARBs)-- Yidabi^®(Azilsartan Medoxomil and Potassium Chloride Tablets) has been approved by the National Medical Products Administration (NMPA) for marketing in China, with the approved indication for the treatment of primary hypertension in adults.

As a new-generation ARB antihypertensive drug, Edarbi^®Its unique oxadiazole ring structure enables it to interact with angiotensinIIBinds more tightly to the type 1 receptor (AT1R) and dissociates more slowly. Currently, Edarbi^®Launched in over 35 countries and regions worldwide, including the United States, Canada, France, and the United Kingdom.

Edarbyclor^®The approval in China was based on Phase III clinical studies in China that demonstrated favorable antihypertensive efficacy and safety. In a multicenter, double-blind, randomized study conducted in the Chinese hypertensive population, azilsartan medoxomil potassium 40 mg showed comparable efficacy to valsartan 160 mg, while azilsartan medoxomil potassium 80 mg demonstrated significantly superior blood pressure-lowering efficacy compared to valsartan 160 mg (P<0.05). In the ambulatory blood pressure monitoring (ABPM) subgroup, both azilsartan medoxomil potassium 40 mg and 80 mg exhibited more pronounced 24-hour sustained antihypertensive effects than valsartan 160 mg. Furthermore, azilsartan medoxomil potassium displayed a safety profile consistent with other angiotensin II receptor blockers (ARBs) in the Chinese population.^[1]。

Professor Wang Jiguang, Chairman of the Chinese Hypertension League and Director of the Shanghai Institute of Hypertension, stated: “Yidabi^®Its approval for marketing in China has provided a new option for clinical antihypertensive treatment in our country. Whether as monotherapy or in combination regimens, Yidabi^®"Can help patients achieve blood pressure targets smoothly and early, enabling efficient and easy blood pressure management."

Professor Wang Jiguang, Chairman of the Chinese Hypertension League and Director of the Shanghai Institute of Hypertension

The Report on Cardiovascular Diseases in China 2020 shows that there are currently approximately 245 million patients with hypertension in China, with a hypertension control rate of only 16.8%.^[2], far below the levels in developed countries in Europe and America, the prevention and control of hypertension still face significant challenges. The "Healthy China 2030" strategy proposes that hypertensive patients require more standardized blood pressure management, with over 70% of patients receiving antihypertensive treatment achieving target blood pressure control.^[3]. Achieving this goal requires not only an advancement in hypertension management concepts, but also more efficacious antihypertensive medications.

In the global, multicenter study of azilsartan medoxomil potassium, White WB et al.^[4]A total of 1,291 patients with grade 1–2 hypertension were enrolled in a 6-week, randomized, double-blind, multicenter, placebo-controlled study. The primary efficacy endpoint was the change in 24-hour systolic blood pressure (SBP) from baseline after 6 weeks of treatment. The results showed that the antihypertensive efficacy of azilsartan medoxomil potassium at doses of 40 mg and 80 mg was superior to that of olmesartan medoxomil 40 mg and valsartan 320 mg. Azilsartan medoxomil potassium 80 mg reduced the 24-hour mean ambulatory SBP by 14.3 mm Hg, compared with a reduction of 10.0 mm Hg for valsartan 320 mg (P<0.001) and 11.7 mm Hg for olmesartan 40 mg (P=0.009). The reduction in blood pressure with azilsartan medoxomil potassium 80 mg was significantly greater than that achieved with the maximum recommended doses of valsartan and olmesartan.

Yidabi^®The launch not only provides clinicians with more treatment options but also helps hypertensive patients in China return to normal life. Upholding the patient-first philosophy, Takeda will continue to deepen its commitment to the cardiovascular field, continuously developing innovative drugs that align with the evolving concepts of chronic disease diagnosis and treatment, thereby contributing to the realization of "Healthy China 2030."

Declaration:

1. This article aims to convey cutting-edge information in the field of medicine and does not constitute a recommendation, promotion, or endorsement of any drug or treatment regimen.

2. If you wish to learn more about disease-related knowledge or information regarding medications, diagnosis, and treatment, please consult a healthcare professional.

[1] Wu J et al. Medicine (Baltimore). 2020;99(32):e21465.

[2] Summary of the Report on Cardiovascular Diseases in China 2018. Chinese Circulation Journal, 2019, 34(3): 209-220.

[3] http://www.gov.cn/xinwen/2019-07/15/content_5409694.htm

[4] White WB, et al. Hypertension. 2011;57:413-20

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