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FDA Gives Nod to Two-in-One Diabetes Pill

Treatment combines dapagliflozin and metformin

A new two-in-one diabetes tablet has been approved by the FDA. The regulatory “okay” went to Xigduo XR (AstraZeneca), which combines the recently launched diabetes treatment dapagliflozin (Farxiga, AstraZeneca) with an older medication, metformin (a biguanide).

Xigduo XR is the first once-daily tablet combining a sodium glucose co-transporter 2 (SGLT2) inhibitor and metformin to win U.S. approval.

The kidney plays a contributing role in maintaining normal glucose balance, in part by filtering and subsequently reabsorbing glucose back into the circulation. SGLT2 is responsible for the majority of glucose re-absorption in the kidney. Selective inhibition of SGLT2 reduces the re-absorption of glucose and allows its removal via the urine.

Xigduo XR is indicated as an adjunct therapy to diet and exercise to improve glycemic control in adults with type-2 diabetes mellitus when treatment with both dapagliflozin and metformin is appropriate.

Xigduo XR is not approved for use in patients with type-1 diabetes or diabetic ketoacidosis. The product label includes a boxed warning for lactic acidosis, a rare but serious metabolic complication that can occur because of the accumulation of metformin during treatment with Xigduo XR.

The product is contraindicated in patients with moderate-to-severe renal impairment; with a history of serious hypersensitivity to dapagliflozin or metformin; or with metabolic acidosis, including diabetic ketoacidosis.

Xigduo XR is available in multiple dosage strengths of dapagliflozin and metformin, including 5 mg/500 mg, 5 mg/1,000 mg, 10 mg/500 mg, and 10 mg/1,000 mg, respectively. The product should be taken once daily in the morning with food with gradual dose escalation to reduce the risk of gastrointestinal side effects due to metformin. The maximum daily recommended dose is 10 mg for dapagliflozin and 2,000 mg for metformin.

Sources: Reuters; October 30, 2014; and Xigduo XR Prescribing Information; October 2014.

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