AstraZeneca and Bristol-Myers’ marketing authorisation application for Onglyza (saxagliptin) has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), for Onglyza. It is intended for the treatment of type 2 diabetes in adults, and can be used as add-on therapy with metformin, a thiazolidinedione or a sulphonylurea.
The positive response was given following the review of CHMP’ comprehensive clinical development program, that included six core phase-III trials assessing the safety and efficacy of saxagliptin as a once daily therapy. They involved 4,148 patients with type 2 diabetes, including 3,021 patients treated with saxagliptin.
CHMP’ positive opinion on Onglyza will now be reviewed by the European Commission. AstraZeneca and Bristol-Myers Squibb expect the European Commission to issue its decision on a marketing authorisation for Onglyza in the EU in coming months.