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Lexicon Cuts Commercial Operation, Focuses On R&D After FDA Letdown

Pipeline Includes Neuropathic Pain, Cardiomyopathy, Obesity

 
• By Mandy Jackson

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.

Lexicon's restructuring plan represents its second round of layoffs this year. (Shutterstock)

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.

Key Takeaways
  • The US FDA said there were deficiencies in Lexicon’s NDA for Zynquista (sotagliflozin) as a treatment for type 1 diabetes patients with CKD that preclude labeling discussions at this time.

The Woodlands, TX-based Lexicon received notification from the FDA that there were deficiencies in the NDA for Zynquista (sotagliflozin) as...

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