Bristol-Myers Squibb Company (NYSE: BMY), and AstraZeneca (NYSE: AZN) today announced that KOMBIGLYZE™ XR (saxagliptin and metformin HCl extended-release), approved by the U.S. Food and Drug Administration (FDA) on November 5, 2010, is now available by prescription in pharmacies across the United States. KOMBIGLYZE XR is the first and only once-a-day metformin extended-release (XR) plus dipeptidyl peptidase-4 (DPP-4) inhibitor combination tablet offering strong glycemic control across glycosylated hemoglobin levels (HbA1c), fasting plasma glucose (FPG) and post-prandial glucose (PPG).
“KOMBIGLYZE XR (saxagliptin and metformin HCl extended-release) now provides patients with the first once-a-day DPP-4 inhibitor and metformin XR combination tablet containing two complementary therapies that can improve key measures of glucose control including glycosylated hemoglobin levels, fasting plasma glucose and postprandial glucose, in a convenient once-a-day treatment regimen.”
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.
"Type 2 diabetes is a chronic, progressive and multi-factorial disease, and over time, patients often require more than one medication to address the multiple defects associated with the disease," said Matthew Mintz, M.D., FACP, The George Washington University School of Medicine. "KOMBIGLYZE XR (saxagliptin and metformin HCl extended-release) now provides patients with the first once-a-day DPP-4 inhibitor and metformin XR combination tablet containing two complementary therapies that can improve key measures of glucose control including glycosylated hemoglobin levels, fasting plasma glucose and postprandial glucose, in a convenient once-a-day treatment regimen."
KOMBIGLYZE XR is contraindicated in patients with renal impairment, metabolic acidosis including diabetic ketoacidosis, and hypersensitivity to metformin. KOMBIGLYZE XR should be temporarily discontinued in patients undergoing radiologic studies with iodinated contrast materials.
The Centers for Disease Control and Prevention (CDC) estimate that approximately one in every 11 adults in the United States has diagnosed diabetes. Type 2 diabetes accounts for approximately 90 to 95% of all cases of diagnosed diabetes in adults.
Bristol-Myers Squibb Company and AstraZeneca