Bristol-Myers Squibb and AstraZeneca have submitted an NDA to the FDA and a MAA to the EMEA for Onglyza (saxagliptin) for the treatment of type 2 diabetes.
The submissions are based on data from a clinical program conducted in addition to standard therapies, as well as in treatment naïve patients as a monotherapy. The program included studies that evaluated the drug at doses as high as 80 times therapeutic clinical doses. The six Phase III trials assessed the safety and efficacy of saxagliptin and involved more than 4,000 patients.
Onglyza, under joint development by BMS and AZ, is a DPP-4 inhibitor designed to be a selective, reversible inhibitor of the DPP-4 enzyme, with dual routes of clearance. Additional Phase III data for saxagliptin, including when added to a sulfonylurea, a thiazolidinedione and as initial combination therapy with metformin, are planned for disclosure later this year.