Search for content, post, videos

FDA approves AstraZeneca’s XIGDUO

The US Food and Drug Administration has approved AstraZeneca’s once-daily XIGDUO XR (dapagliflozin and metformin hydrochloride extended-release) for the treatment of adults with type 2 diabetes.

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 glycaemic control in adults with type 2 diabetes mellitus when treatment with both dapagliflozin and metformin is appropriate.

“The addition of XIGDUO XR to our US 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 personalised approach to disease management.”

XIGDUO XR is already approved in Australia for the treatment of adults with type 2 diabetes, along with diet and exercise. XIGDUO (dapagliflozin and metformin hydrochloride), which uses an immediate-release form of metformin, is approved in the European Union.

Source: AstraZeneca pressrelease