Sunday, 05 February 2023

China approves AstraZeneca's Forxiga for CKD in patients with & without type-2 diabetes

06 September 2022 | News

Approval marks the first SGLT2 inhibitor approved in China for chronic kidney disease in adult patients with and without type-2 diabetes

Image credit: EMA

Image credit: EMA

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 worldwide. However, diagnosis rates remain low and up to 90% of patients are unaware they have the disease.

Forxiga (known as Farxiga in the US) is now approved in 100 countries around the world including the US, the European Union and Japan for the treatment of CKD in adults with and without T2D.


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