Astra's diabetes drug a step closer to EU release

26th Jun 2009 07:34

London-listed drugs giant AstraZeneca and US pharmaceuticals major Bristol-Myers Squibb said their jointly developed treatment for type 2 diabetes has cleared a regulatory hurdle in Europe.Astra said its marketing authorisation application for ONGLYZA (saxagliptin) was received positively by 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 CHMP reviewed data from an extensive clinical development programme that included six core Phase III trials assessing the safety and efficacy of saxagliptin as a once daily therapy.The CHMP’s verdict on ONGLYZ will now be reviewed by the European Commission which provides marketing authorisation on drugs in the European Union.