After discussions with representatives of the Food and Drug Administration regarding its diabetes drug lixisenatide, France-based Sanofi had decided to withdraw its New Drug Application (NDA) rather than have the FDA review interim data, Sanofi announced [link opens in PDF] today.
Lixisenatide is approved for use in several countries, including Mexico, Japan, Australia, and across Europe, for treating Type 2 diabetes in adults, the company said. However, Sanofi's NDA for lixisenatide included early data on its ELIXA cardiovascular outcomes study, and there are concerns from the company that if early results of the study were to become public, it could compromise the ongoing study's integrity.
As a result, Sanofi has determined it would be more appropriate to wait for the FDA's evaluation of lixisenatide until the completion of the ELIXA study in approximately 15 months. Sanofi added in its statement that its decision to withdraw the NDA "is not related to safety issues or deficiencies in the NDA."
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