Sanofi SA Provides Update on Lixisenatide New Drug Application in United States


Thursday, 12 Sep 2013 01:00am EDT 

Sanofi SA announced its decision to withdraw the lixisenatide New Drug Application (NDA) in the United States, which included early interim results from the ongoing ELIXA cardiovascular (CV) outcomes study. The company plans to resubmit the NDA in 2015, after completion of the ELIXA CV study. The decision to withdraw the lixisenatide application follows discussions with the United States Food and Drug Administration (FDA) regarding its proposed process for the review of interim data. Sanofi SA believes that potential public disclosure of early interim data, even with safeguards, could potentially compromise the integrity of the ongoing ELIXA study. Sanofi SA’s decision is not related to safety issues or deficiencies in the NDA. The ELIXA study continues as planned and is fully enrolled. Complete results should be available in approximately 15 months. Therefore, Sanofi SA came to the conclusion that the most appropriate option is to support the FDA’s evaluation of lixisenatide based on the complete results of the ELIXA study rather than interim data. The combination of lixisenatide and Lantus (basal insulin), the investigational LixiLan fixed-ratio product, remains on schedule to enter into phase 3 in the first half of 2014. 

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