AstraZeneca PLC (LSE: AZN) and Bristol-Myers Squibb Co (NYSE: BMY) said their marketing authorisation application for type 2 diabetes drug ONGLYZA (saxagliptin) received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP).
The CHMP’s opinion will now be reviewed by the European Medicines Agency (EMEA) which has the authority to implement an EU-wide marketing approval for the drug.
The application covers the use of ONGLYZA 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 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.
AstraZeneca and Bristol-Myers Squibb expect the EMEA to issue its decision on a marketing authorisation for this type 2 diabetes investigational drug in the European Union in the coming months.
The companies entered into a collaboration in January 2007 to research, develop and commercialise two investigational drugs for type 2 diabetes - saxagliptin and dapagliflozin.