Sanofi: Lixisenatide moves one step forward in the US
BUY, Fair Value EUR80 (+11%)
Sanofi announced this morning that NDA for lixisenatide was accepted by the FDA for review which should translate into an action date sometime in October 2013. The NDA was based on the GetGoal programme which included 11 trials and more than 5 000 patients suffering from type II diabetes most of which uncontrolled despite different treatment lines including basal insulin. The filing also included some data from the cardiovascular outcome study ELIXA that was required by the US agency. This acceptance of filing should not come as a big surprise however.
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