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Kombiglyze XR

Generic name: saxagliptin and metformin
Treatment for: Diabetes, Type 2

Update: Kombiglyze XR (saxagliptin and metformin) Now FDA Approved - November 5, 2010

FDA Accepts NDA for Fixed Dose Combination Of Onglyza (Saxagliptin) and Extended Release Metformin

U.S. Food And Drug Administration Accepts New Drug Application For Once-Daily Fixed Dose Combination Of Onglyza (Saxagliptin) And Extended Release Metformin For The Treatment Of Type 2 Diabetes Mellitus In Adults

PRINCETON, N.J. & WILMINGTON, Del.-- Bristol-Myers Squibb Company and AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for an investigational fixed dose combination of Onglyza (saxagliptin), a dipeptidyl peptidase-4 (DPP4) inhibitor, and metformin HCl extended-release tablets as a once-daily treatment for type 2 diabetes mellitus in adults. Bristol-Myers Squibb and AstraZeneca submitted the NDA with the U.S. FDA for saxagliptin/metformin HCl extended-release tablets on December 29, 2009.

The NDA is based on bioequivalence data and data from the Onglyza phase 3 clinical trial program which included studies for the co-administration of Onglyza and immediate release metformin, as an adjunct to diet and exercise, in adult patients with type 2 diabetes inadequately controlled on metformin alone and in treatment-naïve adult patients.

About Onglyza

Onglyza has been submitted for regulatory review in more than 50 countries and is approved in 38 countries, including the United States and member states of the European Union. Onglyza was approved by the FDA in July 2009 and is indicated as an adjunct to diet and exercise to improve blood sugar (glycemic) control in adults for the treatment of type 2 diabetes mellitus. Onglyza once daily can be used in combination with commonly prescribed oral anti-diabetic medications – metformin, sulfonylureas or thiazolidinediones (TZD) – or as a monotherapy to significantly reduce glycosylated hemoglobin (A1C) levels. Onglyza should not be used for the treatment of type 1 diabetes or for the treatment of diabetic ketoacidosis (high levels of certain acids, known as ketones, in the blood or urine). Onglyza has not been studied in combination with insulin.

Important Information About Onglyza (saxagliptin)

Indication and Important Limitations of Use

Onglyza is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Onglyza should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.

Onglyza has not been studied in combination with insulin.

Important Safety Information

* Use With Medications Known to Cause Hypoglycemia: Insulin secretagogues, such as sulfonylureas, cause hypoglycemia. Therefore, a lower dose of the insulin secretagogue may be required to reduce the risk of hypoglycemia when used in combination with Onglyza. * Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Onglyza or any other antidiabetic drug.

Most common adverse reactions (regardless of investigator assessment of causality) reported in ≥5 percent of patients treated with Onglyza and more commonly than in patients treated with control were upper respiratory tract infection (7.7 percent, 7.6 percent), headache (7.5 percent, 5.2 percent), nasopharyngitis (6.9 percent, 4.0 percent) and urinary tract infection (6.8 percent, 6.1 percent). When used as add-on combination therapy with a thiazolidinedione, the incidence of peripheral edema for Onglyza 2.5 mg, 5 mg, and placebo was 3.1 percent, 8.1 percent and 4.3 percent, respectively.

Drug Interactions: Because ketoconazole, a strong CYP 3A4/5 inhibitor, increased saxagliptin exposure, the dose of Onglyza should be limited to 2.5 mg when coadministered with a strong CYP 3A4/5 inhibitor (e.g., atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin).

Patients with Renal Impairment: The dose of Onglyza (saxagliptin) is 2.5 mg once daily for patients with moderate or severe renal impairment, or with end-stage renal disease requiring hemodialysis (creatinine clearance ?? mL/min). Onglyza should be administered following hemodialysis. Onglyza has not been studied in patients undergoing peritoneal dialysis. Assessment of renal function is recommended prior to initiation of Onglyza and periodically thereafter.

Pregnant and Nursing Women: There are no adequate and well-controlled studies in pregnant women. Onglyza, like other antidiabetic medications, should be used during pregnancy only if clearly needed. It is not known whether saxagliptin is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when Onglyza is administered to a nursing woman.

Pediatric Patients: Safety and effectiveness of Onglyza in pediatric patients have not been established.

Please see accompanying US Full Prescribing Information for Onglyza or visit www.bms.com.

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 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, please visit www.bms.com.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialization of prescription medicines. As a leader in gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease medicines, AstraZeneca generated global revenues of $32.8 billion in 2009. In the United States, AstraZeneca is a $14.8 billion healthcare business.

For more information about AstraZeneca in the US or our AZ&Me™ Prescription Savings programs, please visit: www.astrazeneca-us.com or call 1-800-AZandMe (292-6363).

Onglyza is a trademark of the Bristol-Myers Squibb Company.

Contacts

Media: Bristol-Myers Squibb Ken Dominski, 609-252-5251 ken.dominski@bms.com

Posted: March 2010

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