US regulators have approved AstraZeneca’s Xigduo XR, giving patients with diabetes type II access to the first once-daily pill combining the SGLT2 inhibitor dapagliflozin and metformin HCl extended-release.
The US Food and Drug Administration has given the all clear for the drug’s use as an adjunct therapy to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both dapagliflozin, which is also marketed standalone as Forxiga, and metformin is appropriate.
The pill offers two anti-hyperglycaemic agents with complementary mechanisms of action, with dapagliflozin blocking the reabsorption of glucose by the kidney and metformin suppressing glucose production by the liver.
Xigduo XR’s approval “provides prescribers and adult patients with another treatment choice, supporting a more personalised approach to disease management”, noted Elisabeth Björk, Head of Cardiovascular & Metabolism, Global Medicines Development at AZ.
Diabetes is estimated to affect 29.1 million people in the US, with type II forms accounting for about 90%-95% of cases.
Xigduo XR is already approved in Australia along with diet and exercise, while Xigduo, which uses an immediate-release form of metformin, is cleared for use in the European Union.