Posted by Michael Wonder on 24 May 2018
FDA to review Zynquista (sotagliflozin) as potential treatment for type 1 diabetes
22 May 2018 - The U.S. FDA has accepted Sanofi's regulatory filing for Zynquista (sotagliflozin). The investigational oral treatment would be used in addition to insulin therapy to improve blood sugar control in adults with type 1 diabetes.
The FDA new drug application for sotagliflozin is based on data from the inTandem clinical trial program which includes three Phase 3 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.
The target FDA action date under the Prescription Drug User Fee Act is anticipated to be 22 March 2019. Sanofi also submitted a regulatory application to the EMA earlier this year.
