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news.Bristol-Myers Squibb Company and AstraZeneca have submitted a new drug application to the FDA and validation of a marketing authorization application to the European Medicines Agency for Onglyza.
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The Onglyza (saxagliptin), a dipeptidyl peptidase-4 (DPP-4) enzyme inhibitor, is an investigational drug under joint development by Bristol-Myers Squibb and AstraZeneca for the treatment of type 2 diabetes.
The companies have proposed the name Onglyza which, if approved by the FDA and the European Medicines Agency, will serve as the trade name for saxagliptin.
The new drug application and marketing authorization application 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.
The clinical trial program included studies that evaluated the drug at up to 80 times therapeutic clinical doses. The six core Phase III trials assessing the safety and efficacy of saxagliptin involved more than 4,000 patients, including 3,000 who were treated with saxagliptin.