Lexicon Pharmaceuticals Announces FDA Advisory Committee Meeting for Zynquista
Advisory Committee Meeting Set; PDUFA Goal Date Remains Unchanged
Lexicon Seeks Approval for ZYNQUISTA™ (sotagliflozin) as an Addition to Insulin Therapy for Glycemic Control in Adults with Type 1 Diabetes and Chronic Kidney Disease
Today, Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced that the U.S. Food and Drug Administration (FDA) plans to hold a meeting of the Endocrinologic and Metabolic Drugs Advisory Committee to discuss Zynquista™ (sotagliflozin). This medication is intended as an adjunct to insulin therapy for managing glycemic control in adults who have type 1 diabetes and chronic kidney disease (CKD). The meeting is scheduled, and the current PDUFA goal date is set for further assessment.
“Lexicon is eager to present the extensive evidence that supports the positive benefit/risk profile of sotagliflozin for glycemic control in individuals with type 1 diabetes and CKD,” stated Dr. Mike Exton, chief executive officer and director.
About Lexicon Pharmaceuticals
Lexicon is a biopharmaceutical company committed to developing groundbreaking medicines that improve patients’ lives. Through its Genome5000 program, Lexicon researchers have examined nearly 5,000 genes, identifying over 100 protein targets with considerable therapeutic potential across a range of diseases. By specifically targeting these proteins, Lexicon is advancing the discovery and development of innovative treatments. The company has already launched INPEFA (sotagliflozin) in the United States and has a promising pipeline addressing neuropathic pain, diabetes, metabolism, and other conditions.
Media and Investor Inquiries Contact
For any media or investor inquiries, please reach out to:
Lisa DeFrancesco
Lexicon Pharmaceuticals, Inc.
lexinvest@lexpharma.com
Frequently Asked Questions
What is Zynquista used for?
Zynquista (sotagliflozin) is intended to be used alongside insulin therapy to assist in managing glycemic control for 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 an upcoming date to assess its approval.
What is Lexicon Pharmaceuticals focused on?
Lexicon Pharmaceuticals is dedicated to pioneering innovative medicines by utilizing its genomics target discovery platform to investigate therapeutic possibilities across various diseases.
What is the current status of sotagliflozin?
Sotagliflozin is presently under review for use in combination with insulin therapy for type 1 diabetes, while Lexicon continues to explore and develop additional drug candidates.
How can I contact Lexicon Pharmaceuticals for inquiries?
You can contact Lexicon Pharmaceuticals via email at lexinvest@lexpharma.com for any media or investor-related questions.