FDA OKs Xigduo XR, a New Dapagliflozin-Metformin Combo

Miriam E. Tucker

October 30, 2014

The US Food and Drug Administration (FDA) has approved a once-daily combination of dapagliflozin and metformin hydrochloride extended-release (Xigduo XR, AstraZeneca) for the treatment of adults with type 2 diabetes.

The once-daily oral tablet is the first in the United States to combine the sodium glucose cotransporter-2 inhibitor dapagliflozin (trade name Farxiga in the United States) with the biguanide extended-release (XR) metformin hydrochloride, according to an AstraZeneca statement.

The new combination is indicated for use as an adjunct to diet and exercise in adults in whom treatment with both dapagliflozin and metformin is appropriate. The combination is already approved in Australia for the same indication, whereas a slightly different version is approved in the European Union, containing an intermediate-release formulation of metformin.

Several different doses of the dapagliflozin/metformin hydrochloride combination are available, including 5 mg/500 mg, 5 mg/1000 mg, 10 mg/500 mg, and 10 mg/1000 mg, allowing for the starting dose to be individualized according to the patient's current treatment regimen. Maximum daily recommended doses are 10 mg for dapagliflozin and 2000 mg for metformin.

The pill should be taken in the morning with food, and the dose should be escalated gradually to reduce the risk for gastrointestinal adverse effects from the metformin.

The FDA's approval of the combination was based on four phase 3 clinical trials demonstrating efficacy and safety of the separate dapagliflozin and metformin intermediate-release or XR tablets in treatment-naive patients and those inadequately controlled on metformin, as well as when compared with the combination of a sulfonylurea plus metformin.

There have been no clinical studies of the combination pill itself in patients with diabetes, but bioequivalence was demonstrated in healthy adults between the combination pill and the separate tablets, according to AstraZeneca.


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