FDA again spells out safety concerns with oral type 1 diabetes drug while denying Lexicon's attempt to overturn a CRL
Back in March 2019, the FDA made clear to Sanofi and its partner Lexicon Pharmaceuticals — Sanofi has since left the picture — that it couldn’t approve the application for their type 1 diabetes drug because the data submitted do not show that the drug is safe.
“The data demonstrated that the addition of sotagliflozin to insulin is associated with an increased risk of diabetic ketoacidosis (DKA), a serious and often life-threatening consequence of insulin insufficiency,” the agency said in a rare explanation of the complete response letter. “Time-to-event analyses of the clinical trial data showed earlier development of DKA in sotagliflozin-treated patients than in patients assigned to placebo, without evidence that the risk stopped increasing over time.”
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