Forxiga approved in China for the treatment of chronic kidney disease in patients at risk of progression with and without type-2 diabetes

发布时间： 2022-09-12 阅读：305次

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September 5, 2022 --AstraZeneca’s Forxiga (dapagliflozin), a sodium-glucose cotransporter 2 (SGLT2) inhibitor, has been approved in China to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease (ESKD), cardiovascular (CV) death and hospitalisation for heart failure (hHF) in adults with chronic kidney disease (CKD) at risk of progression with and without type-2 diabetes (T2D).

The approval by China’s National Medical Products Administration (NMPA) is based on positive results from the DAPA-CKD Phase III trial.

CKD is a serious, progressive condition defined by decreased kidney function and is often associated with an increased risk of heart disease or stroke. The condition affects 850 million people worldwide5. However, diagnosis rates remain low and up to 90% of patients are unaware they have the disease.

Member of the DAPA-CKD Executive Committee, Fan Fan Hou, Southern Medical University, Guangzhou, China, said: “With unprecedented results of DAPA-CKD, dapagliflozin becomes the first SGLT2 inhibitor approved in China for the treatment of chronic kidney disease. This transformational milestone brings great hope to the 120 million subjects suffering from chronic kidney disease in China.”

Sir Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca said: “In addition to AstraZeneca’s commitment to drive increased awareness, prevention and earlier diagnoses, this approval marks another important step forward in our ambition to stop, reverse and ultimately cure chronic kidney disease globally. We are thrilled at the opportunity to bring Forxiga to millions of patients across the country and improve patient outcomes.”