AstraZeneca announced Thursday that the FDA approved Xigduo XR (dapagliflozin/metformin) as an adjunct therapy to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus. The company noted that the therapy is the first once-daily tablet combining an SGLT2 inhibitor, in the form of Farxiga (dapagliflozin), and extended-release metformin to be cleared in the US.
According to AstraZeneca, the FDA's decision was based on data from four Phase III studies that provided clinical evidence of the efficacy and safety of dapagliflozin and metformin tablets in treatment-naïve patients, in patients inadequately controlled on metformin, as well as compared to a sulfonylurea plus metformin. The drugmaker said that no clinical trials have been conducted with Xigduo XR, but bioequivalence has been demonstrated in healthy adults between the combination therapy and dapagliflozin plus extended-release metformin as separate tablets.
Elisabeth Björk, head of cardiovascular and metabolism, global medicines development at AstraZeneca, noted that "the approval of...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, while Xigduo, which uses an immediate-release form of metformin, was authorised by the European Commission earlier this year.
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