Lexicon Resubmits Sotagliflozin NDA for Type 1 Diabetes

Lexicon Pharmaceuticals, a Texas-based biopharmaceutical company, announced on June 21, 2024, that it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for sotagliflozin. This drug is intended to be used alongside insulin therapy for managing glycemic levels in individuals with type 1 diabetes and chronic kidney disease (CKD).

Lonnel Coats, the CEO and director of the company, expressed confidence in sotagliflozin's benefit-risk profile for those battling type 1 diabetes and CKD. He emphasized that the company is committed to finding a regulatory path to bring this potentially life-changing therapy to market. This resubmission marks a crucial step toward providing an additional treatment option for those patients.

The journey for sotagliflozin has been ongoing. In 2019, the FDA issued a complete response letter (CRL) regarding the initial NDA for sotagliflozin for type 1 diabetes. In 2021, Lexicon requested a public Notice of Opportunity for Hearing (NOOH) from the FDA to explore whether there were reasons to deny the drug's approval. By the end of 2023, both parties agreed to pause the NOOH proceedings to discuss a possible pathway for resubmission and potential approval. Currently, the application is filed with the FDA, and Lexicon expects a formal response within 30 days. The regulatory review period is anticipated to take six months, which may lead to a potential drug launch in early 2025.

Lexicon Pharmaceuticals is known for its pioneering approach in developing medicines that transform patients' lives. Through its Genome5000™ program, Lexicon has studied nearly 5,000 genes to identify over 100 protein targets with significant therapeutic potential across various diseases. This targeted approach has led to the development of innovative treatments aimed at safely and effectively combating diseases.

One of Lexicon's significant achievements is the commercial launch of INPEFA® (sotagliflozin) in the United States. Besides sotagliflozin, the company has an array of promising drug candidates in various stages of development aimed at treating conditions such as neuropathic pain, diabetes and metabolism disorders, among others.

This resubmission is a testament to Lexicon's commitment to addressing unmet medical needs. If approved, sotagliflozin could offer a new adjunctive therapy for individuals with type 1 diabetes and CKD, potentially improving their quality of life and disease management.

Lexicon's approach to drug discovery and development showcases their dedication to leveraging genetic insights to create groundbreaking treatments. Their strategy involves precise targeting of proteins discovered through their genomics platform, which holds promise for the treatment of a wide range of diseases.

The potential approval of sotagliflozin could mark a significant milestone for Lexicon Pharmaceuticals, reinforcing their position as innovators in the biopharmaceutical industry. The company continues to focus on meeting regulatory requirements and advancing its clinical and preclinical pipeline to bring more effective therapies to market.

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