EU approves BMS, Astra diabetes drug

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The European Commission has granted marketing authorization for Onglyza (saxagliptin) from Bristol-Myers Squibb (BMS) and AstraZeneca to treat type 2 diabetes.

According to the companies, Onglyza is indicated as a once-daily 5 mg oral tablet dose in adult patients with type 2 diabetes mellitus to improve glycemic control:
  • In combination with metformin, when metformin alone, with diet and exercise, does not provide adequate glycemic control;
  • In combination with a sulphonylurea, when sulphonylurea alone, with diet and exercise, does not provide adequate glycemic 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 glycemic control in patients for whom use of a thiazolidinedione is considered appropriate.

Onglyza belongs to the class of dipeptidyl peptidase-4 (DPP-4) inhibitors. These are designed to enhance the body's ability to decrease glucose when it is elevated by acting on the natural hormones, incretins, thereby increasing insulin production, and by reducing the liver's production of glucose, the New York City-based BMS and London-based AstraZeneca said.

The launch of Onglyza is expected to begin in the fourth quarter of this year.