Source – AstraZeneca
On June 27, 2023, AstraZeneca’s Xigduo XR, a once-daily fixed-dose combination of dapagliflozin and metformin hydrochloride extended-release, has received approval from China’s National Medical Products Administration (NMPA) for the treatment of adults with type-II diabetes (T2D). This approval allows Xigduo XR to be used as an adjunct to diet and exercise in order to improve glycemic control.
Xigduo XR combines two anti-hyperglycemic agents, dapagliflozin (also known as Forxiga) and metformin hydrochloride extended-release, in a single oral tablet. Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor, which has already been approved in China for the treatment of T2D, heart failure with reduced ejection fraction (HFrEF), and chronic kidney disease (CKD). This fixed-dose combination of dapagliflozin and metformin is the only one of its kind approved in China and provides a first-line treatment option to improve glycemic control in patients with T2D.
“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.”
– Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca
In China, there are approximately 129 million people living with T2D, accounting for more than 90% of the total diabetes population. Many T2D patients struggle to maintain adequate glycemic control, with 60% failing to reach target blood glucose levels. Prolonged high blood glucose levels can lead to severe complications such as cardiovascular disease and kidney damage. Poor adherence to complex drug regimens is a contributing factor to suboptimal glycemic control, as more than half of T2D patients need to take between 3-6 tablets daily.
The approval by China’s NMPA was based on a local bioequivalence study and supported by the global diabetes program for Xigduo XR, which provided clinical evidence of the efficacy and safety profile of dapagliflozin and metformin immediate-release or extended-release tablets in patients who had inadequate glycemic control while on metformin. Xigduo XR is approved in the US, Australia and other regions.