FDA Approves Once-Daily Oral Combination Treatment for Type 2 Diabetes

AstraZeneca today announced that the US Food and Drug Administration has approved once-daily Xigduo XR (dapagliflozin and metformin hydrochloride extended-release) for the treatment of adults with type 2 diabetes mellitus.

Xigduo XR combines two anti-hyperglycemic agents with complementary mechanisms of action, dapagliflozin, 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 glycemic control in adults with type 2 diabetes mellitus when treatment with both dapagliflozin and metformin is appropriate.

Xigduo XR is not recommended for patients with type 1 diabetes or diabetic ketoacidosis. The product label for Xigduo XR contains a boxed warning for lactic acidosis, a rare, but serious metabolic complication that can occur due to metformin accumulation during treatment with Xigduo XR.

Xigduo XR is contraindicated in patients with moderate to severe renal impairment, a history of a serious hypersensitivity to dapagliflozin or to metformin HCl, or with metabolic acidosis, including diabetic ketoacidosis.

“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,” said Elisabeth Björk, Head of Cardiovascular & Metabolism, Global Medicines Development, AstraZeneca. “The approval of once-daily Xigduo XR provides prescribers and adult patients with another treatment choice, supporting a more personalized approach to disease management.”