Lexicon Pharmaceuticals has not completely given up on sotagliflozin after the US Food and Drug Administration issued a “deficiencies preclude discussion” letter regarding the new drug application (NDA) seeking approval to treat adults with type 1 diabetes and chronic kidney disease (CKD). However, Lexicon said on 22 November that it will restructure, shuttering its commercial organization and ending promotion of sotagliflozin in its approved heart failure indication.
Lexicon Cuts Commercial Operation, Focuses On R&D After FDA Letdown
Pipeline Includes Neuropathic Pain, Cardiomyopathy, Obesity
With a US FDA determination that sotagliflozin cannot be approved for type 1 diabetes at this time, Lexicon is shutting down its commercial organization to focus on its R&D pipeline.
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Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
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