JDRF Statement on FDA Complete Response Letter for Zynquista™
JDRF is disappointed that the U.S. Food and Drug Administration (FDA) has not approved sotagliflozin (Zynquista™) at this time for adults with type 1 diabetes (T1D). It is critical that we add new therapy options for people with T1D in order to address the unmet needs of our community. We expect that the FDA and drug manufacturers will continue working together to safely bring this option to people with T1D in the future and are thankful for FDA’s consideration and review of this drug. In the meantime, we will continue to research new treatments to better manage T1D and are also looking forward to the availability of other options in the pipeline.