FDA grants approval to Xigduo XR from AstraZeneca

WILMINGTON, Del. — AstraZeneca on Thursday announced that the Food and Drug Administration approved Xigduo XR (dapagliflozin and metformin hydrochloride extended-release), a once-daily drug for the treatment of adults with Type 2 diabetes. 

 

Xigduo XR is the first and only once-daily combo tablet of an SGLT2 inhibitor and metformin extended-release to be approved in the United States, according to AstraZeneca. It is indicated as an adjunct therapy to diet and excercise to improve glycemic control in adults with Type 2 diabetes mellitus when treatment with both dapagliflozin and metformin is appropriate, the company stated. It is not recommended for patients with Type 1 diabetes or 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 and 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.”