Sanofi has withdrawn its new drug application (NDA) in the United States for lixisenatide, an antidiabetes drug, which included early interim results from the ongoing ELIXA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 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. According to Sanofi, the 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. Sanofi states 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 III in the first half of 2014.