Lexicon updates on Zynquista NDA resubmission
Texas, USA-based biopharma Lexicon Pharmaceuticals (Nasdaq: LXRX) announced that the US Food and Drug Administration (FDA) has acknowledged the resubmission of its New Drug Application (NDA) for Zynquista (sotagliflozin) as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and chronic kidney disease (CKD).
The FDA indicated that it considers the resubmission to be a complete response to the FDA’s 2019 action letter regarding the sotagliflozin NDA for type 1 diabetes, providing a Prescription Drug User Fee Act (PDUFA) goal date of December 20, 2024. Lexicon’s shares closed up 5.2% at $2.23 on the news yesterday.000
“Lexicon has continued confidence in the favorable benefit/risk profile of sotagliflozin for adults with type 1 diabetes and CKD. With a PDUFA date now in hand, we can begin the next phase of launch preparation for Zynquista,” said Dr Mike Exton, chief executive and director of Lexicon.
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