Press release
Lexicon Pharmaceuticals Announces FDA Advisory Committee Meeting for Zynquista
Advisory Committee Meeting Scheduled for October 31, 2024; PDUFA Goal Date Remains December 20, 2024 Lexicon Seeks Approval for ZYNQUISTA™ (sotagliflozin) as
About this update from Lexicon Pharmaceuticals, Inc.
[{"type":"text","content":"Advisory Committee Meeting Scheduled for October 31, 2024; PDUFA Goal Date Remains December 20, 2024 Lexicon Seeks Approval for ZYNQUISTA™ (sotagliflozin) as an Adjunct to Insulin Therapy for Glycemic Control in Adults with Type 1 Diabetes and Chronic Kidney Disease THE WOODLANDS, Texas, Aug. 21, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today 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. About Lexicon Pharmaceuticals Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Through the Genome5000™ program, Lexicon’s unique genomics target discovery platform, Lexicon scientists studied the role and function of nearly 5,000 genes and identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to treat disease safely and effectively. Lexicon has commercially launched one of these medicines, INPEFA® (sotagliflozin) in the United States, and has a pipeline of other promising drug candidates in discovery and clinical and preclinical development in neuropathic pain, diabetes and metabolism and other indications. For additional information, please visit www.lexpharma.com. Safe Harbor Statement This press release contains “forward-looking statements,” including statements relating to the therapeutic and commercial potential, research and clinical development and regulatory status of sotagliflozin in type 1 diabetes. In addition, th...