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This NDA submission is based on data from two Phase 3 studies, which enrolled more than 1,900 patients worldwide to evaluate the safety and efficacy of the fixed-ratio combination when used in patient populations insufficiently controlled after oral antidiabetic agents (OADs) and after basal insulin therapy, respectively. Both studies met their primary endpoints and will be presented at a medical congress in 2016.The safety and efficacy of the fixed-ratio combination have not been evaluated by any regulatory authority, and the proprietary name is under consideration. Preparations are on track for regulatory submission in the European Union in March 2016. The investigational GLP-1 receptor agonist lixisenatide was evaluated in patients with type 2 diabetes and is also currently under review by the FDA. The NDA for lixisenatide was accepted in September 2015, and an FDA decision is anticipated in July 2016.

http://en.sanofi.com...

Additional Relevant Details Sanofi announced today that it has submitted updated information on the pen delivery device as part of the New Drug Application (NDA) for the investigational once-daily fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide for the treatment of adults with type 2 diabetes. The additional information, submitted at FDA’s request, constitutes a Major Amendment to the NDA, resulting in an extension of the Prescription Drug User Fee Act (PDUFA) goal date by three months, to November 2016.

http://mediaroom.san...

Additional Relevant Details A U.S. regulatory decision on iGlarLixi is now expected before the end of November 2016.

https://www.drugs.co...

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