The first SGLT2 inhibitor to treat chronic kidney disease in adult patients with and without type 2 diabetes has been authorized in China.
Forxiga, a drug made by AstraZeneca (NASDAQ:AZN), has been approved in China to lower the risk of end-stage kidney disease (ESKD), cardiovascular death, and heart failure hospitalization in persons with chronic kidney disease (CKD) at risk of progression with or without type 2 diabetes (T2D).
Data from the phase 3 DAPA-CKD trial served as the basis for China’s National Medical Products Administration’s (NMPA) decision.
In order to compare the effectiveness of Forxiga 10mg to placebo in patients with CKD Stage 2-4 and high urinary albumin excretion, both with and without T2D, the DAPA-CKD trial involved 4,304 patients from throughout the globe and was conducted in multiple international centers. The New England Journal of Medicine published comprehensive trial outcomes.
Fan Fan Hou, a member of the DAPA-CKD Executive Committee from Southern Medical University in Guangzhou, China, stated: “With DAPA-groundbreaking CKD’s results, dapagliflozin is now the first SGLT2 inhibitor to be approved for use in China to treat chronic kidney disease. The 120 million Chinese people who suffer from chronic renal disease now have a lot of optimism thanks to this revolutionary milestone.
The British pharmaceutical company said that Forxiga (dapagliflozin), also known as Farxiga in the United States, is now authorized in 100 nations across the world, including the United States, the European Union, and Japan, for the treatment of CKD in people with and without T2D.
Reduced kidney function is the hallmark of CKD, a dangerous, progressive disorder that is frequently linked to an elevated risk of heart disease or stroke. 850 million individuals worldwide are affected by the ailment, yet detection rates are still poor and up to 90% of sufferers are not aware they have the illness.
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