Lexicon Pharma Announces FDA Advisory Committee Meeting For Zynquista

(RTTNews) - Lexicon Pharmaceuticals, Inc. (LXRX), Wednesday announced that the U.S. Food and Drug Administration (FDA) expects to convene a meeting of the Endocrinologic and Metabolic Drugs Advisory Committee for Zynquista (sotagliflozin) as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and chronic kidney disease (CKD) on October 31, 2024, with no change to the PDUFA goal date of December 20, 2024.

According to the notice provided, the FDA intends to make the background materials available to the public no later than two business days before the meeting.

"Lexicon looks forward to the opportunity to share the breadth of evidence that has been generated to support the favorable benefit/risk profile of sotagliflozin for glycemic control in people with type 1 diabetes and CKD," said Dr. Mike Exton, chief executive officer and director.