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Lexicon Loses Appeal of Complete Response Letter for Diabetes Treatment

December 13, 2019

Lexicon Pharmaceuticals has lost its appeal to the FDA of the agency’s complete response letter in March for its investigational add-on type 1 diabetes treatment Zynquista (sotagliflozin).

In a conference call for investors, the company’s CEO Lonnel Coats said the Office of New Drugs continues to maintain that the application could not be approved in its current form.

The agency sent the drugmaker and its co-developer Sanofi a complete response letter two months after the Endocrinologic and Metabolic Drugs Advisory Committee deadlocked over the drug’s safety profile.

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