KOMBIGLYZE XR Approved for the Treatment of Type 2 Diabetes


Bristol-Myers Squibb Company and AstraZeneca announced FDA approval of KOMBIGLYZE XR, the first and only once-a-day metformin extended-release (XR) plus dipeptidyl peptidase-4 (DPP-4) inhibitor combination tablet for the treatment of type 2 diabetes in adults. KOMBIGLYZE XR offers strong glycemic control across glycosylated hemoglobin levels (HbA1c), fasting plasma glucose (FPG) and post-prandial glucose (PPG).

KOMBIGLYZE XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin and metformin is appropriate. KOMBIGLYZE XR should not be used for patients with type 1 diabetes or diabetic ketoacidosis and has not been studied in combination with insulin.Consistent with the Prescribing Information (PI) for metformin alone, the PI for KOMBIGLYZE XR contains a boxed warning for lactic acidosis, a rare, but serious metabolic complication that can occur due to metformin accumulation during treatment with KOMBIGLYZE XR.

Once-a-day KOMBIGLYZE XR combines saxagliptin (also known as ONGLYZA™), a DPP-4 inhibitor, and metformin XR, a biguanide, in one tablet for the treatment of type 2 diabetes. KOMBIGLYZE XR should generally be administered once a day with the evening meal, with gradual dose titration to reduce the gastrointestinal side effects associated with metformin. The maximum daily recommended dose is 5 mg for saxagliptin and 2,000 mg for metformin extended-release.

For the full press release click here.

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