Key points:
- Lexicon resubmits NDA for sotagliflozin as an adjunct to insulin therapy for type 1 diabetes patients with CKD.
- The resubmission follows multiple interactions and recent feedback from the FDA.
- Lexicon expects a six-month regulatory review period, with an action date to be communicated within 30 days.
Lexicon Pharmaceuticals has taken a significant step forward in its quest to bring a novel treatment to type 1 diabetes patients with chronic kidney disease (CKD). The company has resubmitted its New Drug Application (NDA) for sotagliflozin to the U.S. Food and Drug Administration (FDA), following extensive discussions with the agency.
This resubmission marks a crucial milestone for Lexicon, coming after a complete response letter in 2019 and subsequent discussions with the FDA. Lonnel Coats, Lexicon’s CEO, expressed confidence in sotagliflozin’s benefit/risk profile and the company’s commitment to bringing this potential therapy to market.
Sotagliflozin, if approved, could offer a new treatment option for type 1 diabetes patients with CKD, addressing an unmet medical need in this population. The drug’s development is part of Lexicon’s broader mission to pioneer transformative medicines based on its unique genomics target discovery platform.
As the diabetes community awaits the FDA’s decision, this resubmission represents a potential turning point in the management of type 1 diabetes complicated by CKD, offering hope for improved glycemic control and patient outcomes.
