The once-daily fixed-dose combination has been approved for type-2 diabetes by the NMPA as an adjunct to diet and exercise for the improvement of glycaemic control
AstraZeneca secures approval from China’s NMPA for Xigduo XR in type-2 diabetes. (Credit: AstraZeneca)
AstraZeneca has secured approval for Xigduo XR (dapagliflozin and metformin hydrochloride extended-release) from China’s National Medical Products Administration (NMPA) for the treatment of adults with type-2 diabetes (T2D).
The once-daily fixed-dose combination is approved as an adjunct to diet and exercise for the improvement of glycaemic control.
Xigduo XR is already approved in the US, Australia, and other countries.
It is a combination of two anti-hyperglycaemic agents that have complementary mechanisms of action in a once-daily oral tablet.
Dapagliflozin, which is branded as Forxiga, is a sodium-glucose cotransporter 2 (SGLT2) inhibitor. It has approval in China for the treatment of adults with T2D, heart failure with reduced ejection fraction (HFrEF), as well as chronic kidney disease (CKD).
Metformin hydrochloride (HCl) extended release is a biguanide.
According to AstraZeneca, Xigduo XR is the only fixed-dose combination of this type to be approved in China.
AstraZeneca biopharmaceuticals business unit executive vice president Ruud Dobber 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. 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.”
The approval of Xigduo XR by the NMPA was backed by a local bioequivalence study, as well as the drug’s global diabetes programme’s clinical evidence regarding the efficacy and safety of dapagliflozin and metformin in both immediate-release (IR) and XR formats. The data was especially pertinent for patients whose condition was not adequately managed with metformin alone.