Why did FDA reject sotagliflozin? Safety concerns outweighing benefits in Type 1 diabetes
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3 min read
In late 2024, the FDA's advisory committee delivered an 11-3 vote against approving sotagliflozin (brand name Zynquista) for type 1 diabetes patients with chronic kidney disease. This decision marked the second major setback for the drug in this indication, as the FDA rejected sotagliflozin once again over persistent and unmitigated concerns about a heightened risk of diabetic ketoacidosis (DKA).
