AstraZeneca Launches Andash® (Dapagliflozin and Metformin Extended-Release Tablets) in China, Offering a Novel Once-Daily Fixed-Dose Combination Therapy for Adults with Type 2 Diabetes

A New Treatment Option for Chinese Diabetes Patients to Control Blood Sugar and Protect Heart and Kidney

ShanghaiNovember 23, 2023PR Newswire -- November 22, 2023, AstraZeneca announced Andasutravir^®(General name: Dapagliflozin Metformin Sustained-Release Tablets), this combination drug for type 2 diabetes, has officially been launched in China. Professor Linong Ji from Peking University People's Hospital, Professor Dalong Zhu from Nanjing Drum Tower Hospital, and Professor Dajin Zou from Tongren Hospital affiliated with Shanghai Jiao Tong University School of Medicine, along with many other interdisciplinary experts and scholars in China, attended this grand event to jointly witness the arrival of another innovative new drug in the field of diabetes.

Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets is a combination medication that incorporates two antihyperglycemic drugs with complementary mechanisms of action: dapagliflozin (brand name: Forxiga), a sodium-glucose co-transporter-2 (SGLT2) inhibitor previously approved in China for the treatment of adult type 2 diabetes, symptomatic chronic heart failure, and chronic kidney disease, and metformin hydrochloride extended-release tablets, an oral biguanide tablet taken once daily. This is currently the only such*A once-daily, fixed-dose combination of an SGLT2 inhibitor and extended-release metformin hydrochloride, dapagliflozin and metformin extended-release tablets provide a first-line treatment option for improving glycemic control in patients with type 2 diabetes.

High Sugar Harms the Heart and Kidneys, Controlling Sugar Protects the Heart and Kidneys Equally

The Number of Diabetes Patients in China is Approximately 129 Million^[1], where type 2 diabetes accounts for more than 90% of the entire diabetic population.^[2]. However, the situation of diabetes prevention and treatment is not optimistic. Data shows that many patients with type 2 diabetes have poor blood glucose control, and 60% of patients' blood glucose levels are not within the target range.^[3]On the other hand, the biggest problem faced by diabetic patients in clinical practice is cardiorenal complications. Diabetes is an independent risk factor for cardiovascular and cerebrovascular diseases.^[4]Compared with the non-diabetic population, the risk of cardiovascular and cerebrovascular diseases in diabetic patients increases by 2 to 4 times, and about 80% of diabetic patients eventually die from cardiovascular events.^[4]. In addition, about one-third of diabetes cases are associated with kidney disease.^[5], 30%-50% of kidney failure is caused by diabetes^[6], requiring kidney transplantation or long-term dialysis.

"The Guidelines for the Prevention and Treatment of Type 2 Diabetes in China (2020 Edition)" points out that the short-term goal of diabetes treatment is to eliminate diabetes symptoms and prevent acute complications by controlling hyperglycemia and metabolic disorders, while the long-term goal is to achieve the purpose of preventing cardiovascular and renal complications, improving patients' quality of life, and prolonging life expectancy through good metabolic control.

Dual Mechanisms Combine for Multiple Patient Protections

Professor Ji Linong stated, "The strategy and concept of treating and managing type 2 diabetes by focusing equally on glycemic control and improving cardiovascular and renal outcomes have increasingly resonated with medical professionals. The treatment model now comprehensively considers achieving glycemic targets while prioritizing cardio-renal protection, adhering to the principle of 'early treatment, early target achievement, early protection.' The arrival of Dapagliflozin and Metformin Sustained-Release Tablets provides a new therapeutic approach for achieving both short-term and long-term goals in diabetes treatment, offering 'one solution, dual protection.'"

At the same time, medication adherence is crucial for disease management in patients with diabetes, and factors influencing medication adherence include the convenience of taking medication. Currently, more than half of patients with type 2 diabetes need to take 3-6 tablets per day.^[8]Studies have shown that patients using only one oral hypoglycemic agent have 45% higher medication adherence over a continuous one-year period compared to those using two agents simultaneously.^[9]。

Professor Zou Dajin pointed out: "As a compound preparation, dapagliflozin metformin sustained-release tablets have two complementary mechanisms of action, which also help simplify the treatment regimen, better improve patient compliance, and help patients achieve blood glucose control and cardio-renal protection."

AstraZeneca China General Manager Leon Lai stated: "Improving blood glucose control rates and reducing cardiovascular and renal complications are critical tasks in China's diabetes prevention and treatment, as well as unmet needs for patients. Over the thirty years since AstraZeneca entered China, we have consistently upheld the patient-centered philosophy, deeply understood patient needs, and continuously developed and introduced innovative drugs with the aim of delivering comprehensive benefits to patients. We hope that the accelerated approval and application of dapagliflozin metformin sustained-release tablets in China will soon provide patients with a simplified treatment option that achieves blood sugar control while protecting the heart and kidneys, improving prognosis and quality of life in multiple ways."

About2Type 2 Diabetes

Type 2 diabetes is a chronic disease characterized by pathophysiological defects leading to elevated glucose levels or hyperglycemia.^[7]. Over time, persistent hyperglycemia will lead to the further progression of the disease.^[7]It is estimated that by 2045, the number of people with diabetes will reach 783 million.^[7]In China, type 2 diabetes accounts for more than 90% of the entire diabetic population.^[2]Many patients have poor blood glucose control, low medication adherence, and there remains a significant unmet medical need.^[7,8]

About Dapagliflozin Metformin Sustained-Release Tablets

Dagliflozin and Metformin Sustained-Release Tablets are the first compound formulation combining dagliflozin (SGLT2 inhibitor) and metformin sustained-release agent (biguanide), taken once daily, in conjunction with diet control and exercise. It is suitable for adult patients with type 2 diabetes who are appropriate candidates for treatment with both dagliflozin and metformin hydrochloride to improve glycemic control.

About Dapagliflozin

Dapagliflozin is the first-in-class sodium-glucose cotransporter-2 (SGLT2) inhibitor, taken orally once daily. As scientific research continues to uncover the underlying connections between the heart, kidneys, and pancreas, studies have also demonstrated dapagliflozin's efficacy in slowing cardiorenal disease progression and providing organ protection.^[10-12]. Damage to a single organ can lead to dysfunction in other organs, which is also a major cause of death worldwide, including conditions such as type 2 diabetes, heart failure, and chronic kidney disease (CKD).^[13-15]。

About AstraZeneca's Cardiovascular, Renal and Metabolic Therapy Areas

Cardiovascular, renal, and metabolic diseases have always been important therapeutic areas and growth engines for AstraZeneca, both globally and in China. By following the science to better understand the underlying connections between the heart, kidneys, liver, and pancreas, AstraZeneca is actively engaged in the research and development of innovative drugs to effectively protect organs, slow or halt disease progression, and aims to improve patients' lives through the development of regenerative therapies. AstraZeneca is committed to combating the mechanisms driving these interconnected diseases by gaining a deeper understanding of the interrelationships among cardiovascular, renal, and metabolic conditions, enabling patients to receive earlier and more effective detection, diagnosis, and treatment, thereby improving and saving millions of lives.

*As of November 2023

Disclaimer: This material does notFor any promotional purposes, the relevant information should not be used as treatment or usage advice. For any related questions, please consult a healthcare professional.

References:

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[3].     Yu Xu, et al. Prevalence and Control of Diabetes in Chinese Adults. JAMA. 2013;310(9):948-958.

[4].     Wang Weiqing. Guidelines for Metabolic Disease Management of the National Standardized Metabolic Diseases Management Center (MMC) (Second Edition)[J]. Chinese Journal of Endocrinology and Metabolism, 2023, 39(06): 538-554.

[5].     Chinese Diabetes Society of Chinese Medical Association. Chinese Journal of Diabetes 2018,10(1):4-67

[6].     Tuttle KR, Bakris GL,Bilous RW, et al. Diabetic kidney disease: a report from an ADA Consen-sus Conference. Diabetes Care 2014;37:2864-2883

[7].     International Diabetes Federation [Internet]. IDF Diabetes Atlas Tenth Edition 2021. [cited 2023 June 20]. Available from: https://diabetesatlas.org/idfawp/resource-files/2021/07/IDF_Atlas_10th_Edition_2021.pdf 

[8].     Blüher M, et al. Pill Burden in Patients With Type 2 Diabetes in Germany: Subanalysis From the Prospective, Noninterventional PROVIL Study. 2015; 33(2): 55–61.

[9].     Dailey G, Kim MS, Lian JF. Patient compliance and persistence with anti-hyperglycemic therapy: evaluation of a population of type 2 diabetic patients[J].J Int Med Res,2002,30(1);71-79.

[10].  McMurray JJV, et al. Dapagliflozin in patients with heart failure and reduced ejection fraction. N Engl J Med. 2019;381(21):1995–2008.

[11].  Heerspink HJL, et al. Dapagliflozin in patients with chronic kidney disease. N Engl J Med. 2020;383(15):1436-1446.

[12].   Wiviott SD, et al; for the DECLARE-TIMI 58 Investigators. Dapagliflozin and cardiovascular outcomes in type 2 diabetes [article and supplementary appendix]. N Engl J Med. 2019;380(4):347-357.

[13].   Mayo Clinic [Internet]. Heart failure [cited 2023 June 20]. Available from: https://www.mayoclinic.org/diseases-conditions/heart-failure/symptoms-causes/syc-20373142.

[14].  Centers for Disease Control and Prevention (CDC) [Internet]. A snapshot: Diabetes in the United States [cited 2023 June 20]. Available from: https://www.cdc.gov/diabetes/library/socialmedia/infographics/diabetes.html.

[15].  National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) [Internet]. Heart disease & kidney disease [cited 2023 June 20]. Available from: https://www.niddk.nih.gov/health-information/kidney-disease/heart-disease.