Lexicon Pharmaceuticals has submitted additional clinical data to the US Food and Drug Administration (FDA) from ongoing third-party funded, investigator-initiated studies supporting the potential resubmission of the New Drug Application for Zynquista® (sotagliflozin), an oral SGLT1/SGLT2 inhibitor, as an adjunct to insulin for glycaemic control in adults with type 1 diabetes (T1D).
The submission of additional clinical data follows a complete response letter issued by the FDA in December 2024 that cited concerns of increased risk of diabetic ketoacidosis. Based on subsequent discussions with FDA regarding potential regulatory paths forward, Lexicon has been granted a Type D meeting and has submitted data from three ongoing studies of sotagliflozin conducted by the Steno Diabetes Center (STENO1)1, the Joslin Diabetes Center (SUGARNSALT)2 and the University of Dundee (SOPHIST)3 supporting the benefit-risk profile of Zynquista in T1D.
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