AstraZeneca’s Xigduo XR approved in China for adults with type-2 diabetes

Betsy Goodfellow | June 27, 2023 | News story | Medical Communications AstraZeneca, China, Diabetes, Xigduo XR, diabetes 

AstraZeneca has announced that its Xigduo XR (dapagliflozin and metformin hydrochloride extended-release), a once-daily fixed-dose combination, has now been approved by China’s National Medical Products Administration (NMPA) for the treatment of adults with type-2 diabetes.

The drug is intended to be used alongside diet and exercise to improve glycaemic control, and combines two anti-hyperglycaemic agents with complementary mechanisms of action: dapagliflozin and metformin hydrochloride extended release. Xigduo XR is now the only fixed-dose combination of its kind to be approved in China, providing a new first-line treatment option to improve glycaemic control in type-2 diabetes patients.

This approval follows a local bioequivalence study of the drug in China, and is supported by the global diabetes programme for Xigduo XR which provided evidence of the drug’s safety and efficacy.

Ruud Dobber, executive vice president of the BioPharmaceuticals Business Unit at AstraZeneca, comnmented: “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. Today’s 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.”

Betsy Goodfellow

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