Breaking News, Trials & Filings

BMS, AZ Submit NDA and MAA for Onglyz

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By: Tim Wright

Editor-in-Chief, Contract Pharma

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 saxa...

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