China approves Xigduo XR for adults with type-2 diabetes

27 June 2023

China’s National Medical Products Administration (NMPA) has approved Xigduo XR (dapagliflozin and metformin hydrochloride extended-release), a once-daily fixed-dose combination, for the treatment of adults with type-2 diabetes (T2D) as an adjunct to diet and exercise to improve glycemic control, from UK pharma major AstraZeneca (LSE: AZN).

Xigduo XR, which is approved in the USA, Europe, Australia and other regions, combines two anti-hyperglycemic agents with complementary mechanisms of action: dapagliflozin (trade name, Forxiga), a sodium-glucose cotransporter 2 (SGLT2) inhibitor, which has been approved in China for the treatment of adults with T2D, heart failure with reduced ejection fraction (HFrEF) and chronic kidney disease (CKD), and metformin hydrochloride (HCl) extended release, a biguanide, in a once-daily oral tablet.

It is the only fixed-dose combination of this kind to be approved in China and provides a first-line treatment option that can improve glycemic control in T2D patients.

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