Letter to the FDA Urging the Agency Not to Approve the New Drug Application for Sotagliflozin for Treating Type 1 Diabetes

March 11, 2019

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Public Citizen strongly urged the Food and Drug Administration (FDA) not to approve the new drug application (NDA) for sotagliflozin (ZYNQUISTA) for use as an adjunct to insulin therapy to improve glycemic control in adults with type 1 diabetes because the data from the phase 3 clinical trials presented in the NDA show that the drug causes an unacceptable eight-fold increased risk of life-threatening diabetic ketoacidosis in subjects with type 1 diabetes given the drug, compared with those given a placebo.

March 21, 2019, FDA response letter.