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Zealand Pharma A/S Announces Decision by Sanofi to Withdraw NDA for Lixisenatide in United States to Resubmit upon Completion of ELIXA Cardiovascular Outcomes Study


Thursday, 12 Sep 2013 01:50am EDT 

Zealand Pharma A/S announced that Sanofi has decided to withdraw the New Drug Application (NDA) for lixisenatide in the United States (U.S.) and resubmit in 2015 after completion of the ongoing ELIXA cardiovascular (CV) outcome study. The NDA filed for lixisenatide was accepted for review by the U.S. Food and Drug Administration (FDA) in February 2013, including early interim results from the ELIXA study. The decision by Sanofi to withdraw the application follows discussions with the FDA regarding the authorities’ proposed process for the review of these interim data. It is Sanofi’s belief that potential public disclosure of interim data, even with safeguards, could potentially compromise the integrity of the entire ELIXA study of up to 6,000 patients, as it is still ongoing. The withdrawal of the NDA by Sanofi is thus not related to any safety issues or deficiencies in the NDA. The ELIXA study continues as planned and has been fully enrolled. Sanofi expects complete study results to be available in early 2015. 

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