Sanofi temporarily pulls lixisenatide NDA in USA

12 September 2013

French drug major Sanofi (Euronext: SAN) this morning (September 12) announced its decision to withdraw the diabetes drug candidate lixisenatide New Drug Application in the USA, 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. Lixisenatide was in-licensed from Denmark’s Zealand Pharma (Nasdaq OMX Copenhagen: ZEAL). Zealand’s shares plunged 20.5% to 62.oo euros in early trading while Sanofi dipped 1.2% to 73.39 euros.

The decision to withdraw the lixisenatide application follows discussions with the US Food and Drug Administration 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 says its decision is not related to safety issues or deficiencies in the NDA.

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