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| |  European Commission Approves Saxagliptin for Type 2 Diabetes NEW YORK -- October 5, 2009 -- The European Commission has granted marketing authorisation for saxagliptin (Onglyzatm) as a once-daily 5 mg oral tablet dose for adult patients with type 2 diabetes. Saxagliptin can be used in combination with metformin, when metformin alone, with diet and exercise, does not provide adequate glycaemic control; in combination with a sulphonylurea, when sulphonylurea alone, with diet and exercise, does not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate; or in combination with a thiazolidinedione, when the thiazolidinedione alone, with diet and exercise, does not provide adequate glycaemic control in patients for whom use of a thiazolidinedione is considered appropriate. The approval is based on data submitted from a comprehensive clinical development programme that included 6 core phase 3 registrational trials and a phase 3b study comparing saxagliptin plus metformin with sitagliptin plus metformin. The registrational trials assessed the safety and efficacy of saxagliptin and involved 4,148 patients with type 2 diabetes, including 3,021 patients treated with saxagliptin.
SOURCE: Bristol-Myers Squibb and AstraZeneca
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