China’s National Medical Products Administration (NMPA) has granted approval for AstraZeneca’s Xigduo XR (dapagliflozin and metformin hydrochloride extended-release) to treat type-2 diabetes (T2D) in adult patients.
Xigduo XR is indicated for increasing glycaemic control, as an adjunct to exercise and diet.
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Offered as a once-a-day fixed-dose combination, the product merges dapagliflozin (Forxiga) and metformin hydrochloride (HCl) extended-release, both of which are anti-hyperglycaemic agents.
The latest development was based on a bioequivalence study and is supported by the international diabetes programme for Xigduo XR. These provided clinical proof of the safety and efficacy of the fixed-dose combination regimen in patients whose T2D was not controlled effectively by metformin.
Xigduo XR has also received approval for usage in Australia and the US.
AstraZeneca biopharmaceuticals executive vice-president Ruud Dobber stated: “People living with T2D 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.”
This month, the NMPA approved the company’s Soliris (eculizumab) for treating adults with refractory generalised myasthenia gravis.
