Sanofi In Pole Position In Oral Type 1 Diabetes With Zynquista Filings
The French drugmaker and partner Lexicon now have a PDUFA date of March 22 next year for their dual inhibitor of SGLT-1 and SGLT-2 which is well placed to become the first oral antidiabetic to get the green light for use by adults with the type 1 form of the disease, in combination with insulin.
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Sanofi's proposed type 1 diabetes treatment may be beneficial for some patients who want more glycemic control and are willing to perform the necessary monitoring, but how would the US FDA define that population in the label?
Some Endocrinologic and Metabolic Drugs Advisory Committee members said a REMS is sufficient, but others worried that proposed risk management plans were not proven effective.
US FDA also questions composite efficacy endpoint used in one of the phase III trials as sotagliflozin reaches advisory committee in attempt to become first approved oral type 1 diabetes treatment. Sanofi says that type 1 diabetes patients already manage DKA risk because it is inherent to their condition and patients did not seem bothered by the instructions to handle DKA.