As the first dual SGLT1/SGLT2 inhibitor developed for use in diabetes, Lexicon’s sotagliflozin has tantalizing potential. But getting the pill to pass muster with the FDA has been problematic.
The latest setback with the U.S. regulator came five weeks ago when Lexicon pulled back a submission for approval in Type 2 diabetes patients with heart failure. That came on top of an FDA rejection for sotagliflozin in 2019 in Type 1 diabetes.
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