AstraZeneca Xigduo XR approved in China for adults with type 2 diabetes
China: AstraZeneca’s Xigduo XR (dapagliflozin and metformin hydrochloride extended-release), a once-daily fixed-dose combination, has been approved by China’s National Medical Products Administration (NMPA) for the treatment of adults with type-2 diabetes (T2D) as an adjunct to diet and exercise to improve glycaemic control.
Xigduo XR combines two anti-hyperglycaemic 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 glycaemic control in T2D patients.
Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca said, “People living with type-2 diabetes often have comorbidities such as heart failure and chronic kidney disease, leading to cardiorenal events which are the primary causes of death and hospitalisation in this patient population. There is a need for effective and innovative therapies that can both lower the occurrence of these events and also help improve treatment adherence, which often undermines glycaemic control. The welcome approval reinforces SGLT2 inhibitors and metformin as foundational treatments for type-2 diabetes patients in China and represents an important step forward in better management of this condition.”
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