China approves Forxiga for chronic kidney disease

UK pharma major AstraZeneca (LSE: AZN) says its 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 hospitalization 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 and marks the first SGLT2 inhibitor cleared in the country for this indication.

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.