FDA advisors divided on T1D drug sotagliflozin

An advisory panel to the FDA voted 8-8 Jan. 17 on a motion to approve the type 1 diabetes drug sotagliflozin, Reuters reported.

Sotagliflozin, the brainchild of Texas-based Lexicon Pharmaceuticals and the French brand Sanofi, was proposed as a once-daily oral medication for type 1 diabetics, according to Reuters. The medication is intended as an add-on to traditional insulin therapy.

While Pablo Lapuerta, CMO at Lexicon, told Reuters sotagliflozin could help long-time diabetics manage and maintain safe glucose levels while mitigating their risk of hypoglycemia, FDA officials noted a risk of diabetic ketoacidosis that’s given some advisors pause.

“I was not convinced it was a reasonable tradeoff,” Martha Nason, a panel member who voted against the approval, said.

Still, patients who were treated with the drug said it steadied their blood sugar levels and helped them lose weight. Lexicon and Sanofi are also proposing a risk evaluation and mitigation strategy, which would require patients to regularly test their ketone levels for safety reasons.

The FDA is slated to make a decision regarding sotagliflozin by March 22.

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