Lexicon Pharmaceuticals has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for sotagliflozin (Zynquista™) as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and chronic kidney disease (CKD). The resubmission follows multiple interactions and feedback from the FDA, marking a significant step toward potentially bringing this therapy to market.
The FDA has acknowledged the resubmission and has set a Prescription Drug User Fee Act (PDUFA) goal date of December 20, 2024. This date indicates when the FDA is expected to make a decision on the application. The FDA considers this resubmission a complete response to the agency’s 2019 action letter regarding the sotagliflozin NDA for type 1 diabetes.
Addressing Unmet Needs in Type 1 Diabetes and CKD
Type 1 diabetes, an autoimmune condition, requires lifelong insulin therapy to manage blood glucose levels. However, achieving optimal glycemic control can be challenging, and the presence of CKD further complicates treatment. Sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, offers a potential therapeutic option to improve glycemic control in this vulnerable population.
Lonnel Coats, director and chief executive officer of Lexicon, stated, “We are confident in the benefit/risk profile of sotagliflozin for people with type 1 diabetes and CKD, and our team has been resolute in identifying and pursuing a regulatory path forward.”
Sotagliflozin's Mechanism of Action
Sotagliflozin inhibits both SGLT1 and SGLT2, which are responsible for glucose absorption in the intestine and reabsorption in the kidneys, respectively. By inhibiting these transporters, sotagliflozin can reduce blood glucose levels and potentially offer additional benefits for patients with type 1 diabetes and CKD.
Lexicon's Pipeline and Discovery Platform
Lexicon Pharmaceuticals is a biopharmaceutical company focused on pioneering medicines through its Genome5000™ program. This platform studies the role and function of nearly 5,000 genes to identify protein targets with therapeutic potential. Lexicon has already launched INPEFA® (sotagliflozin) in the United States for heart failure and has a pipeline of drug candidates in development for neuropathic pain, diabetes, and other indications.
Dr. Mike Exton, chief executive officer and director, commented, “If approved, this will mark Lexicon’s second NDA approval and commercial launch in two years of products that originated from our novel discovery platform and advanced to regulatory approval and commercialization.”
