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(Alliance News) - AstraZeneca PLC on Tuesday said its Xigduo XR combination treatment has received approval in China for type-2 diabetes.
The Cambridge-based pharmaceutical company said the treatment received approval from China's National Medical Products Administration as an adjunct to diet and exercise to improve glycaemic control.
Xigduo XR is a combination of two anti-hyperglycaemic agents, dapagliflozin, which is a sodium-glucose cotransporter 2 inhibitor that trades under the Forxiga brand, and metformin hydrochloride.
The treatment is delivered in a once-daily fixed-dose oral tablet.
"It is the only fixed-dose combination of this kind to be approved in China and provides a first-line treatment option that can improve glycaemic control in T2D patients," Astra explained.
There are around 129 million people with type 2 diabetes in China, with patients often having poor glycaemic control. Sustained high levels of blood glucose can cause organ damage, and result in life-threatening complications including cardiovascular disease and kidney damage.
Low medication adherence resulting from complex drug regimens can contribute to low glycaemic control, Astra said, with a majority of T2D patients needing to take three to six tablets a day.
"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," said Ruud Dobber, executive vice president at Astra's BioPharmaceuticals business unit.
"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."
Shares in AstraZeneca were 0.2% higher at 11,316.00 pence each in London on Tuesday morning.
By Elizabeth Winter, Alliance News senior markets reporter
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