Onglyza Obtains Positive Opinion From CHMP

Published: 25-Jun-2009

CHMP’ positive opinion on Onglyza to be reviewed by the European Commission

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.

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