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# Panel Deadlocks on Lexicon/Sanofi Diabetes Drug
- URL: https://www.fdaweb.com/panel-deadlocks-on-lexicon-sanofi-diabetes-drug/
- Published: 2019-01-22T12:00:00.000Z
- Updated: 2026-09-15T00:56:00.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143191

FDA’s Endocrinologic and Metabolic Drugs Advisory Committee has voted 8 to 8 on whether to recommend approval for Lexicon Pharmaceuticals Inc and Sanofi’s sotagliflozin for treating Type 1 diabetes as an add-on to insulin therapy. Panel members were concerned about a safety signal that FDA raised in a [briefing document](https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM629485.pdf?ref=fdaweb.com) released in advance of the meeting. Medical reviewers said a serious adverse event for sotagliflozin is the consistent and clinically meaningful increase in the risk of diabetic ketoacidosis (DKA) compared to placebo observed in all three Phase 3 clinical trials. “While all patients with Type 1 diabetes may to some degree be at risk for DKA, sotagliflozin therapy clearly increases that risk, and the risk may be unpredictable,” they said.

The companies offered FDA a risk management plan that included doctor and patient education (including emphasis on more frequent testing and recognizing early signs of DKA), but some panel members expressed concern that this could be inadequate in a real-world setting.

FDA said sotagliflozin is an orally administered inhibitor of both sodium-glucose co-transporter 1 and sodium-glucose co-transporter 2\. It does not alter the underlying pathophysiology of Type 1 diabetes but lowers plasma glucose by increasing urinary glucose excretion.