THE WOODLANDS, Texas - Lexicon Pharmaceuticals , Inc. (NASDAQ:LXRX) announced today its plans to resubmit a New Drug Application (NDA) for sotagliflozin, intended as an adjunct to insulin therapy for glycemic control in patients with type 1 diabetes and chronic kidney disease (CKD). The company is targeting mid-2024 for the resubmission, following recent discussions with the FDA.
Sotagliflozin was previously under review by the FDA, which resulted in a complete response letter (CRL) in 2019. Lexicon requested a public Notice of Opportunity for Hearing (NOOH) in 2021 to discuss potential grounds for approval. The NOOH proceedings were put on hold late in 2023 to allow for further discussions about a potential path forward.
"We have remained steadfast in our support of sotagliflozin in type 1 diabetes and have worked diligently to identify a regulatory path forward for what we believe will be an important new therapy," said Lonnel Coats, Lexicon's CEO. "We will now focus those efforts on resubmitting our NDA by mid-year and seeking regulatory approval as early as possible for the many people with type 1 diabetes who have CKD."
The anticipated six-month review period by the regulatory body could mean that if approved, sotagliflozin could be available for patients by the end of the year or early 2025.
Lexicon Pharmaceuticals is a biopharmaceutical company that has been involved in the discovery and development of drugs through its Genome5000™ program. The program has led to the identification of numerous protein targets with therapeutic potential across a variety of diseases. Lexicon has successfully brought multiple medicines to market and continues to develop a pipeline of promising drug candidates in areas such as heart failure, neuropathic pain, diabetes, metabolism, and other indications.
This news is based on a press release statement from Lexicon Pharmaceuticals, Inc.
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