Lexicon Pharmaceuticals Gets December 20, 2024 PDUFA Date for Sotagliflozin Type 1 Diabetes NDA

Lexicon Pharmaceuticals, Inc., based in The Woodlands, Texas, announced that the U.S. Food and Drug Administration (FDA) has acknowledged the resubmission of its New Drug Application (NDA) for Zynquista™ (sotagliflozin). This medication is intended as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and chronic kidney disease (CKD). The FDA has deemed the resubmission as a complete response to its 2019 action letter concerning the initial sotagliflozin NDA for type 1 diabetes. A Prescription Drug User Fee Act (PDUFA) goal date has been set for December 20, 2024.

Dr. Mike Exton, CEO and director of Lexicon Pharmaceuticals, expressed his confidence in the favorable benefit/risk profile of sotagliflozin for the specified patient group. With the PDUFA date established, the company can now move forward with the next phase of launch preparation for Zynquista. If approved, this will be Lexicon's second NDA approval and commercial launch in two years, showcasing the potential of products derived from their innovative discovery platform. The company is poised for strong future value creation for all stakeholders, bolstered by a diverse and exciting portfolio of assets.

Lexicon Pharmaceuticals is dedicated to pioneering medicines that significantly improve patients' lives. Through its unique Genome5000™ program, Lexicon scientists have examined the role of nearly 5,000 genes, identifying over 100 protein targets with substantial therapeutic potential across various diseases. By precisely targeting these proteins, the company is at the forefront of discovering and developing innovative treatments that are both safe and effective.

One of Lexicon’s notable achievements includes the U.S. commercial launch of INPEFA® (sotagliflozin), and the company continues to develop a promising pipeline of drug candidates. These candidates are in various stages of discovery, clinical, and preclinical development, focusing on areas such as neuropathic pain, diabetes, metabolism, and other indications.

In summary, Lexicon Pharmaceuticals is advancing its mission of transforming patient care through the development of groundbreaking medicines. With the FDA's recognition of the resubmitted NDA for Zynquista, the company is well-prepared for the potential approval and subsequent commercial launch in early 2025. This progress underscores Lexicon's commitment to leveraging its unique genomics platform for the discovery and development of novel therapeutic solutions.