US FDA approves KOMBIGLYZE XR

RNS Number : 7333V

AstraZeneca PLC

05 November 2010

 



KOMBIGLYZE XR TABLETS APPROVED IN THE US for the Treatment of Type 2 Diabetes Mellitus in Adults

AstraZeneca and Bristol-Myers Squibb Company today announced that the US Food and Drug Administration (FDA) approved KOMBIGLYZE XR for the treatment of type 2 diabetes in adults.  KOMBIGLYZE XR is the first and only once-a-day metformin extended-release (XR) plus dipeptidyl peptidase-4 (DPP-4) inhibitor combination tablet offering strongglycaemic control across glycosylated haemoglobin levels (HbA1c), fasting plasma glucose (FPG) and post-prandial glucose (PPG). 

KOMBIGLYZE XR is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin (also known as ONGLYZA),  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, a DPP-4 inhibitor, and metformin XR, a biguanide, in one tabletfor 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 XR.

"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," said Howard Hutchinson, M.D., Chief Medical Officer, AstraZeneca.  "KOMBIGLYZE XR combines two effective diabetes medications in a simple once-a-day dose for adult patients who need A1c reductions."

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.

The co-administration of saxagliptin and metformin has been well-studied in adult patients with type 2 diabetes inadequately controlled on metformin alone and in treatment-naïve patients inadequately controlled on diet and exercise alone. 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 approved once-a-day KOMBIGLYZE XR based on two Phase III clinical trials and bioequivalence studies.  The two clinical studies evaluated the efficacy and safety of saxagliptin and metformin IR as separate tablets compared to placebo added to metformin IR.  Bioequivalence was demonstrated in healthy adults between KOMBIGLYZE XR and saxagliptin plus metformin XR as separate tablets.

NOTES TO EDITORS:

About KOMBIGLYZE XR

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.

Bristol-Myers Squibb and AstraZeneca Collaboration

Bristol-Myers Squibb and AstraZeneca entered into a collaboration in January 2007 to enable the companies to research, develop and commercialize select investigational drugs for type 2 diabetes. The Bristol-Myers Squibb/AstraZeneca Diabetes collaboration is dedicated to global patient care, improving patient outcomes and creating a new vision for the treatment of type 2 diabetes.

About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialisation of prescription medicines. As a leader in gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease medicines, AstraZeneca generated global revenues of US $32.8 billion in 2009.  For more information please visit: www.astrazeneca.com

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit www.bms.com or follow us on Twitter at http://twitter.com/bmsnews.

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5 November 2010

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