Diabetes Drug Receives Positive Opinion from CHMP

AstraZeneca and Bristol-Myers Squibb have announced that their marketing authorisation application for Onglyza (saxagliptin) has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP).

This is 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.