FDA accepts filing of Zynquista for type 1 diabetes.- Sanofi.
The FDA has accepted Sanofi's regulatory filing for oral Zynquista (sotagliflozin), to be used in addition to insulin therapy to improve blood sugar control in adults with type 1 diabetes. The target FDA action date under the Prescription Drug User Fee Act (PDUFA) is anticipated to be March 22, 2019. Sanofi also submitted a regulatory application to the European Medicines Agency earlier this year.
The FDA New Drug Application for sotagliflozin is based on data from the inTandem clinical trial program which includes three Phase III clinical trials assessing the safety and efficacy of Zynquista in approximately 3,000 adults with inadequately controlled type 1 diabetes. The safety and efficacy data have not yet been evaluated by any regulatory authority.
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