FDA Approves AstraZeneca's XIGDUO XR for Type 2 Diabetes

AstraZeneca announced that the U.S. Food and Drug Administration (FDA) has approved XIGDUO XR (dapagliflozin and metformin hydrochloride extended-release) tablets for once-daily use in adults with type 2 diabetes. This marks the first approval in the U.S. for a once-daily combination tablet containing an SGLT2 inhibitor and extended-release metformin.

XIGDUO XR combines two anti-hyperglycemic agents: dapagliflozin, an SGLT2 inhibitor that removes glucose via the kidneys, and metformin hydrochloride in an extended-release formulation. The medication is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

The approval offers a new treatment option for patients and prescribers, aiming to support a more personalized approach to managing type 2 diabetes. "The approval of once-daily XIGDUO XR provides prescribers and adult patients with another treatment choice," said Elisabeth Björk, Head of Cardiovascular & Metabolism, Global Medicines Development, AstraZeneca.

XIGDUO XR is already approved in Australia, and XIGDUO, containing an immediate-release form of metformin, is approved in the European Union. The FDA's approval was based on data from four Phase III clinical trials evaluating the efficacy and safety of dapagliflozin and metformin.