British-Swedish drugmaker AstraZeneca has received approval from US Food and Drug Administration (FDA) for its once-daily Xigduo XR to treat adult patients with type 2 diabetes.
Xigduo XR is a combination of two anti-hyperglycaemic agents, Farxiga (dapagliflozin), an inhibitor of sodium-glucose cotransporter 2 (SGLT2), and metformin hydrochloride (HCl) extended-release, a biguanide, in a once-daily oral tablet.
AstraZeneca global medicines development head Elisabeth Björk said: “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.
“The approval of once-daily Xigduo XR provides prescribers and adult patients with another treatment choice, supporting a more personalised approach to disease management.”
The once-daily tablet is indicated as an adjunct therapy to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus.
The drug already obtained approval in Australia to treat adults with type 2 diabetes, along with diet and exercise.
Xigduo (dapagliflozin and metformin hydrochloride), which uses an immediate-release form of metformin, has received European Union approval.
According to Astrazeneca, SGLT2 inhibitors are a new class of medicines that remove glucose from the body through the kidneys.
AstraZeneca develops and markets medicines for cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases.