US FDA approves AstraZeneca's Xigduo XR

The US Food and Drug Administration has approved Anglo-Swedish pharma major AstraZeneca’s (LSE: AZN) once-daily Xigduo XR (dapagliflozin and metformin hydrochloride extended-release) for the treatment of adults with type 2 diabetes.

Xigduo XR combines two anti-hyperglycemic agents with complementary mechanisms of action, dapagliflozin (trade name Farxiga in the USA), an inhibitor of sodium-glucose co-transporter 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 USA. 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.