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FDA advisory panel split on sotagliflozin approval

An FDA advisory committee voted 8-8 Thursday over whether the agency should allow Sanofi and Lexicon Pharmaceuticals' Zynquista, or sotagliflozin, to reach the market. Results of three clinical trials involving nearly 3,000 type 1 diabetes patients showed that although the drug helped reduce blood glucose levels, blood pressure and weight, 3.2% of 1,748 patients developed diabetic ketoacidosis, compared with 0.4% of 1,229 patients on placebo.

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