Biopharmaceutical company Sanofi said on Tuesday that it has successfully filed its regulatory filing for Zynquista (sotagliflozin) with the US Food and Drug Administration (FDA) for treating adults with type 1 diabetes.
The company added that the investigational oral treatment would be used in addition to insulin therapy to improve blood sugar control in adults with type 1 diabetes. The target US FDA action date under the Prescription Drug User Fee Act (PDUFA) is anticipated to be 22 March 2019.
Zynquista, which was developed in partnership with Lexicon Pharmaceuticals Inc, is an investigational oral dual inhibitor of SGLT-1 and SGLT-2, proteins that influence how the intestines and kidneys absorb and eliminate sugar (glucose) resulting in improved glucose control and additional clinical benefits.
In conjunction, the US FDA New Drug Application for sotagliflozin is based on data from the company's inTandem clinical trial programme, which includes three Phase 3 clinical trials assessing the safety and efficacy of Zynquista in 3,000 adults with inadequately controlled type 1 diabetes.
Additionally, the company has submitted a regulatory application to the European Medicines Agency earlier this year.
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