Fda approves kombiglyze xr tablets for type 2 diabetes mellitus in adults


Fda approves kombiglyze xr tablets for type 2 diabetes mellitus in adults

Kombiglyze XR tablets for type 2 diabetes treatment in adults has been approved by the Food and Drug Administration (FDA). It is a once daily saxagliptin (Onglyza) and extended-release metformin diabetes medication. According to AstraZeneca and Bristol-Myers Squibb "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 glycaemic control across glycosylated haemoglobin levels (HbA1c), fasting plasma glucose (FPG) and post-prandial glucose (PPG)."

Kombiglyze XR is designed to improve glycemic control in adult patients with type 2 diabetes mellitus when both saxagliptin (Onglyza) and metformin is suitable - treatment should be combined with diet and exercise. It should not be used for type 1 diabetes patients or those with diabetic ketoacidosis, and has not been studied in combination with insulin.

The Prescribing Information for Kombiglyze XR has a boxed warning for lactic acidosis, which can occur because of a metformin build up during treatment.

Howard Hutchinson, M.D., Chief Medical Officer, AstraZeneca, said:

Patients with type 2 diabetes in the United States can be taking four or five medications for various diseases and conditions, which can lead to complicated medication schedules. KOMBIGLYZE XR combines two effective diabetes medications in a simple once-a-day dose for adult patients who need A1c reductions.

US authorities inform that about 1 in every 11 American adults is diagnosed with diabetes, of which 90% to 95% of cases are type 2.

Patients with inadequately controlled diabetes type 2 on metformin alone as well as previously untreated patients with inadequately controlled diabetes with diet and exercise alone, have been extensively studied when administered saxagliptin combined with metformin.

AstraZeneca adds:

There have been no clinical efficacy or safety studies conducted with KOMBIGLYZE XR. Relative bioavailability between Kombiglyze XR and coadministered saxagliptin and metformin immediate-release (IR) tablets has not been conducted.

The FDA based its Kombiglyze XR approval on two Phase 3 studies and bioequivalence trials.

AstraZeneca in a communiqué, wrote:

Kombiglyze XR addresses three key defects in type 2 diabetes, by incorporating the mechanism of saxagliptin (also known as Onglyza), a DPP-4 inhibitor, with metformin, a commonly used glucose lowering agent. With the two active components, saxagliptin and metformin, Kombiglyze XR has a comprehensive mechanism of action that targets and addresses all three key defects in type 2 diabetes for improved glycaemic control: increases insulin secretion in a glucose-dependent manner, decreases hepatic glucose production, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.

Kombiglyze XR is the result of a collaboration between Bristol-Myers Squibb and AstraZeneca.

Source: AstraZeneca

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