Safety concerns lead to a split FDA panel vote on Sanofi/Lexicon diabetes drug
The first potential pill for patients with the less common type 1 diabetes, who produce no insulin, was the subject of an atypical hung jury vote at an FDA panel on Thursday, in which experts were divided evenly over whether the life-threatening risk of diabetic ketoacidosis associated with the drug offset its benefit.
The drug, sotagliflozin, from Lexicon Pharma and Sanofi is being developed for both type I and type II diabetes. It is designed to inhibit two proteins involved in glucose regulation: SGLT1, which is responsible for glucose reabsorption in the GI tract and SGLT2, which is responsible for glucose reabsorption by the kidney. Many existing diabetes drugs only target SGLT2. Although the molecule is currently being tested in a plethora of trials in patients with type II diabetes, the oral drug is currently under FDA review for type 1 diabetics, who face multiple daily injections of insulin, or use an insulin pump, to achieve glycemic control.
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