AstraZeneca and Bristol-Myers Squibb Company have announced that their marketing authorisation application for ONGLYZA (saxagliptin) received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for the treatment of type 2 diabetes in adults as add-on therapy with metformin, a thiazolidinedione or a sulphonylurea.
The positive opinion was reached after the CHMP reviewed data from a comprehensive clinical development programme that included six core Phase III trials assessing the safety and efficacy of saxagliptin as a once daily therapy. These involved 4,148 patients with type 2 diabetes, including 3,021 patients treated with saxagliptin.
Saxagliptin belongs to the class of dipeptidyl peptidase-4 (DPP-4) inhibitors. These are designed to enhance the body’s ability to decrease blood sugar (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.
This application to the CHMP is for use as a once daily 5mg dose in adult patients with type 2 diabetes mellitus to improve glycaemic control:
in combination with metformin, when metformin alone, with diet and exercise, does not provide adequate glycaemic control;
in combination with a sulphonylurea, when the 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 CHMP’s positive opinion on ONGLYZA will now be reviewed by the European Commission which has the authority to approve medicines for the European Union. AstraZeneca and Bristol-Myers Squibb expect the European Commission to issue its decision on a Marketing Authorisation for this type 2 diabetes investigational drug in the European Union in the coming months.