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news.British drugmaker AstraZeneca has received approval from the US Food and Drug Administration for its once-daily XIGDUO XR drug to treat adults with type 2 diabetes.
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XIGDUO XR is a combination of two anti-hyperglycemic agents, dapagliflozin and metformin hydrochloride (HCl) extended-release in a once-daily oral tablet.
It is the first and only once-daily combination tablet of a sodium-glucose cotransporter 2 (SGLT2) inhibitor Dapagliflozin, and metformin HCl extended-release to be approved in the US. Dapagliflozin is marketed as FARXIGA in the US.
SGLT2 are a relatively new class of medicines that remove glucose from the body through the kidneys.
The drug is indicated as an adjunct therapy to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both dapagliflozin and metformin is appropriate.
The company said that the drug is not recommended for patients with type 1 diabetes or diabetic ketoacidosis.
XIGDUO XR’s product label contains a boxed warning for lactic acidosis, a rare, but serious metabolic complication that can occur due to metformin accumulation during treatment with the drug.
AstraZeneca head of Cardiovascular & Metabolism, Global Medicines Development Elisabeth Björk said: "The addition of XIGDUO XR to our U.S. diabetes portfolio is further evidence of AstraZeneca’s commitment to develop new treatment options for patients with type 2 diabetes.
"The approval of once-daily XIGDUO XR provides prescribers and adult patients with another treatment choice, supporting a more personalized approach to disease management."
XIGDUO XR is already approved in Australia to treat adults with type 2 diabetes, along with diet and exercise.