Pharma Focus Asia

AstraZeneca Receives National Medical Products Administration Approval for Xigduo XR

Wednesday, June 28, 2023

AstraZeneca announced the approval of Xigduo XR by China's National Medical Products Administration (NMPA).

Xigduo XR is a once-daily fixed-dose combination medication consisting of dapagliflozin and metformin hydrochloride extended-release. It has been approved for the treatment of adults diagnosed with type-2 diabetes (T2D). This therapy has received regulatory clearance as an adjunct to dietary and exercise interventions, aiming to optimise the management of blood glucose levels and improve glycaemic control in individuals with T2D.

Xigduo XR is a medication that combines two anti- hyperglycaemic agents, dapagliflozin and metformin hydrochloride (HCl) extended release. Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor, which works by reducing the reabsorption of glucose in the kidneys, leading to increased glucose excretion in the urine. It has been approved in China for the treatment of adults with type 2 diabetes (T2D), heart failure with reduced ejection fraction (HFrEF), and chronic kidney disease (CKD).

The approval of Xigduo XR by China's National Medical Products Administration (NMPA) was based on a local bioequivalence study. This study provided evidence that the combination tablet of dapagliflozin and metformin hydrochloride extended release (XR) had comparable bioavailability to the individual immediate-release (IR) or XR tablets of dapagliflozin and metformin.

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