FDA Approves AstraZeneca's Type 2 Diabetes Combination Treatment

AstraZeneca today announced that the FDA has approved once-daily dapagliflozin and metformin hydrochloride extended-release (Xigduo XR) tablets for the treatment of adults with type 2 diabetes mellitus (T2DM).

Xigduo XR combines 2 anti-hyperglycemic agents with complementary mechanisms of action, dapagliflozin (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. It is indicated as an adjunct therapy to diet and exercise to improve glycemic control in adults with T2DM when treatment with both dapagliflozin and metformin is appropriate.

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

The treatment 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 for AstraZeneca, in a press release. “The approval of once-daily Xigduo XR provides prescribers and adult patients with another treatment choice, supporting a more personalized approach to disease management.”