Lexicon Pharma announced that the company has submitted additional clinical data to the 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 glycemic 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), the Joslin Diabetes Center (SUGARNSALT) and the University of Dundee (SOPHIST) supporting the benefit-risk profile of Zynquista in T1D.
“There has been an outpouring of patient support advocating for the approval of Zynquista in T1D,” said Dr. Mike Exton, Ph.D., chief executive officer and director of Lexicon Pharmaceuticals. “While we are no longer investing in clinical programs for Zynquista, we remain committed to exploring all opportunities to bring this medicine to patients, whose support for approval is unwavering.”
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