Bristol-Myers, Astra submits applications to FDA, EU for diabetes drug

Bristol-Myers Squibb and AstraZeneca have submitted a new drug application (NDA) to the FDA, and validation of a marketing authorization application (MAA) to the European Medicines Agency (EMEA) for Onglyza for the treatment of type 2 diabetes.

The companies said that Onglyza (saxagliptin), a dipeptidyl peptidase-4 enzyme inhibitor, is an investigational drug under joint development by Bristol-Myers and AstraZeneca. The companies have proposed the name Onglyza which, if approved by the FDA and the EMEA, will serve as the trade name for saxagliptin.

The NDA and MAA submissions for saxagliptin are based on data from a comprehensive clinical trial program conducted in addition to standard therapies, as well as in treatment naïve patients as a monotherapy, according to the London-based Astra and the Princeton, N.J.-based Bristol-Myers.

The clinical trial program included studies that evaluated the drug at up to 80 times therapeutic clinical doses, the companies said. The six Phase III trials assessing the safety and efficacy of saxagliptin involved more than 4,000 patients, including 3,000 who were treated with saxagliptin.