Diabetes Pill Given a Coin Flip’s Chance of Approval Ahead of FDA Meeting - (Bloomberg via NewsPoints Desk)

  • An FDA advisory committee will meet on January 17 to review Sanofi and Lexicon Pharmaceuticals' investigational diabetes drug sotagliflozin, Bloomberg reported Wednesday.

  • The drug, which will be marketed under the name Zynquista, is intended for use in conjunction with insulin to improve blood sugar control in patients with type 1 diabetes.

  • Safety is likely to be a key concern of the meeting as SGLT-2 inhibitors have been linked to increased risks of diabetic ketoacidosis (DKA).

  • "While all patients with type 1 diabetes may to some degree be at risk for DKA, sotagliflozin therapy clearly increases that risk, and the risk may be unpredictable," FDA staff commented in documents released ahead of the meeting.

  • Gabelli analyst Kevin Kedra estimated that the therapy has a 50 percent chance of approval this year, noting that "a delay appears increasingly probable."

  • "The government shutdown could greatly impede that work or at least serve as a convenient scapegoat for a delayed decision," Kedra continued.

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