Dapagliflozin Receives China Approval for Chronic Kidney Disease Indication, Becoming First SGLT2 Inhibitor for CKD Treatment in the Country

This approval marks dapagliflozin as the first treatment approved in China for adult chronic kidney disease.SGLT2Inhibitor

ShanghaiSeptember 5, 2022/PR Newswire/ -- AstraZeneca's Forxiga^®(Generic name: Dapagliflozin, a sodium-glucose co-transporter-2 [SGLT2] inhibitor) has been approved in China for the treatment of chronic kidney disease (CKD) to reduce the risk of sustained decline in estimated glomerular filtration rate (eGFR), end-stage renal disease, cardiovascular death, and hospitalization for heart failure in adult CKD patients at risk of progression.

The approval by China's National Medical Products Administration (NMPA) was based on the positive results of the DAPA-CKD Phase III trial.^[1]。

Chronic Kidney Disease (CKD) is a serious condition characterized by a progressive decline in kidney function and is often associated with an increased risk of heart disease or stroke.^[2]-[4]. Affecting nearly 850 million people worldwide^[5]However, the diagnosis rate of chronic kidney disease is very low, with up to 90% of patients unaware that they have this condition.^[4]。

Professor Hou Fanfan, member of the DAPA-CKD Study Executive Committee, academician of the Chinese Academy of Sciences, and director of the Department of Nephrology at Nanfang Hospital, Southern Medical University, stated: "Based on the groundbreaking results of the DAPA-CKD study, dapagliflozin has become the first SGLT2 inhibitor approved in China for the treatment of chronic kidney disease. This milestone research outcome brings new hope to China's 120 million chronic kidney disease patients."

Dr. He Jing, Senior Vice President of AstraZeneca Global and President of AstraZeneca Global R&D China Center, stated: "AstraZeneca is committed to continuously advancing drug research in the fields of cardiovascular, renal, and metabolic diseases, comprehensively improving clinical outcomes for patients with related chronic conditions. Dapagliflozin is the first SGLT2 inhibitor approved in China for the treatment of adult chronic kidney disease. This milestone approval provides Chinese chronic kidney disease patients with a new and effective treatment option, marking an important step forward in AstraZeneca's vision to halt, reverse, and ultimately cure chronic kidney disease on a global scale."

AstraZeneca China General Manager Leon Lai Ming-lung stated, "The approval of the new indication for dapagliflozin provides Chinese patients with chronic kidney disease an entirely new treatment option, further confirming the benefits dapagliflozin offers across the three domains of diabetes, cardiovascular disease, and chronic kidney disease. We will continue to focus on patients, accelerating research and development and introducing innovative drugs to bring comprehensive and revolutionary solutions to China's three patient populations of over 100 million each—diabetes, cardiovascular disease, and chronic kidney disease—to address unmet patient needs."

DAPA-CKD Phase III trial showed that, for patients with chronic kidney disease stages 2-4 and elevated urinary albumin, dapagliflozin reduced the relative risk of the primary endpoint (defined as a composite of worsening kidney function, onset of end-stage kidney disease, or cardiovascular or renal death) by 39% (absolute risk reduction [ARR]=5.3%, p<0.0001) compared to placebo when added to standard of care (SoC) treatment with angiotensin-converting enzyme inhibitors or angiotensin receptor blockers. Compared to placebo, dapagliflozin significantly reduced the relative risk of all-cause mortality in patients with chronic kidney disease by 31% (ARR=2.1%, p=0.0035).^[6]The safety and tolerability of dapagliflozin are consistent with the known safety profile of the drug.

Dapagliflozin has been approved in over 100 countries and regions, including the United States, the European Union, and Japan, for the treatment of adult patients with chronic kidney disease, with or without type 2 diabetes.