AstraZeneca Receives FDA Okay for Diabetes Combination Product

AstraZeneca has received US Food and Drug Administration approval for once-daily Xigduo XR (dapagliflozin and metformin hydrochloride extended-release) for the treatment of adults with Type 2 diabetes.

Xigduo XR combines two anti-hyperglycaemic agents with complementary mechanisms of action, dapagliflozin (trade name in the US, Farxiga), an inhibitor of sodium-glucose cotransporter 2 (SGLT2), and metformin hydrochloride (HCl) extended-release, a biguanide, in a once-daily oral tablet. SGLT2 inhibitors are a relatively new class of medicines that remove glucose from the body via the kidneys.

Xigduo XR is the first and only once-daily combination tablet of an SGLT2 inhibitor and metformin HCl extended-release to be approved in the United States. Xigduo XR is indicated as an adjunct therapy to diet and exercise to improve glycaemic control in adults with Type 2 diabetes mellitus when treatment with both dapagliflozin and metformin is appropriate.

Xigduo XR is already approved in Australia for the treatment of adults with Type 2 diabetes, along with diet and exercise. Xigduo  (dapagliflozin and metformin hydrochloride), which uses an immediate-release form of metformin, is approved in the European Union.

Source: AstraZeneca

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