FDA Approved New Type 2 Diabetes Treatment

The FDA has approved once-daily XIGDUO XR, a tablet containing metformin hydrochloride (HCL) and a sodium-glucose cotransporter 2 (SGLT2) inhibitor, for the treatment of type 2 diabetes in adults.

“The addition of XIGDUO XR to our US diabetes portfolio is further evidence of AstraZeneca’s commitment to develop new treatment options for patients with type 2 diabetes,” said Elisabeth Björk, the head of the Cardiovascular & Metabolism, Global Medicines Development at AstraZeneca.
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The combination drug is categorized in a new class of medicine that works by excreting glucose from the body through the kidneys. The drug, which comes in several dosages of dapagliflozin and metformin HCl extended release, respectively, including 5 mg/500 mg, 5 mg/1000 mg, 10 mg/500 mg, and 10 mg/1000 mg, should be prescribed in conjunction with diet and exercise.

XIGDUP XR is the first and currently only once-daily combination tablet that the FDA has approved in the United States containing metformin HCL extended-release and SGLT2 inhibitor.

Australia already approved XIGDUO XR for type 2 diabetes treatment in adults, and the immediate-release tablet, XIGDUO (metformin hydrochloride and dapagliflozin) was approved for treatment in the European Union.

-Michelle Canales

Reference:

AstraZeneca. US FDA approves once-daily XIGDUO XR tablets for adults with type 2 diabetes. October 30, 2014. www.astrazeneca.com/Media/Press-releases/Article/20141030-us-fda-approve-oncedaily-xigduo-xr. Accessed November 4, 2014.