FDA Meeting for Zynquista Approval by Lexicon Pharmaceuticals
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Lexicon Pharmaceuticals Announces FDA Advisory Committee Meeting for Zynquista
Advisory Committee Meeting Scheduled; PDUFA Goal Date Remains
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
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). The meeting is scheduled with the current PDUFA goal date set for further evaluation.
“Lexicon looks forward to sharing the breadth of evidence supporting 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 dedicated to pioneering medicines that transform patients’ lives. Through the Genome5000 program, Lexicon scientists have studied the role and function of nearly 5,000 genes, identifying more than 100 protein targets with significant therapeutic potential across various diseases. By precisely targeting these proteins, Lexicon is advancing the discovery and development of innovative medicines to treat diseases effectively. It has commercially launched INPEFA (sotagliflozin) in the United States and boasts a promising pipeline in neuropathic pain, diabetes, metabolism, and other indications.
Media and Investor Inquiries Contact
For media and investor inquiries, please contact:
Lisa DeFrancesco
Lexicon Pharmaceuticals, Inc.
lexinvest@lexpharma.com
Frequently Asked Questions
What is Zynquista used for?
Zynquista (sotagliflozin) is being proposed as an adjunct to insulin therapy to help manage glycemic control in adults with type 1 diabetes and chronic kidney disease.
When is the FDA meeting scheduled?
The FDA Advisory Committee meeting for Zynquista is scheduled for a forthcoming date to evaluate its approval.
What is Lexicon Pharmaceuticals focused on?
Lexicon Pharmaceuticals focuses on pioneering innovative medicines by leveraging its genomics target discovery platform to explore therapeutic potential in various diseases.
What is the current status of sotagliflozin?
Sotagliflozin is currently under review for use in conjunction with insulin therapy for type 1 diabetes, while Lexicon continues to develop and research other drug candidates.
How can I contact Lexicon Pharmaceuticals for inquiries?
You can reach Lexicon Pharmaceuticals by email at lexinvest@lexpharma.com for any media or investor inquiries.
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