SGLT2 Inhibitors' Warning On Ketoacidosis Recommends Drug Holidays
This article was originally published in The Pink Sheet Daily
Sponsors must also conduct another post-marketing study.
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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?
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.
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