# Sanofi to withdraw lixisenatide NDA from US



## Northerner (Sep 13, 2013)

Sanofi,an integrated global healthcare leader, announced that the company has decided to withdraw lixisenatide New Drug Application (NDA) in the US, 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 US Food and Drug Administration (FDA) regarding its proposed process for the review of interim data. Sanofi believes that potential public disclosure of early interim data, even with safeguards, could potentially compromise the integrity of the ongoing ELIXA study. Sanofi?s decision is not related to safety issues or deficiencies in the NDA.

http://www.pharmabiz.com/NewsDetails.aspx?aid=77610&sid=2


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