FDA panel split on approval of Sanofi, Lexicon's type 1 diabetes drug Zynquista

In an 8-8 vote on Thursday, an FDA advisory panel was divided on whether to recommend approval of Sanofi and Lexicon Pharmaceutical's investigational diabetes drug Zynquista (sotagliflozin). The once-daily dual SGLT-1 and SGLT-2 inhibitor is being considered as an add-on treatment to insulin for adults with type 1 diabetes, with the FDA expected to issue a final decision regarding approval of the drug by March 22. 

In documents released ahead of the panel vote, FDA staff expressed concern regarding the potential link of the SGLT-2 inhibitor class of drugs to an increased risk of diabetic ketoacidosis. 

Lexicon, whose shares dropped as much as 31.8 percent on the news, announced in May last year the filing of an application by Sanofi, seeking FDA approval of Zynquista. Meanwhile, the company disclosed in 2017, that a Phase III study of Zynquista for the treatment of patients with type 1 diabetes on any background insulin therapy met its primary endpoint, with CEO Lonnel Coats saying at the time that the drug was "the first-ever oral anti-diabetic drug candidate to have achieved success in now three consecutive Phase III clinical trials in this population."  

Sanofi licensed global rights to sotagliflozin in 2015 in a deal worth as much as $1.7 billion. The French drugmaker later identified the therapy as one of as many as nine drugs that could be submitted for regulatory approval over an 18-month period. 

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