Lexicon’s Diabetes Drug Zynquista Faces FDA Scrutiny Again Ahead of Advisory Committee Meeting

Regulatory History:
Lexicon Pharmaceuticals' diabetes drug Zynquista (sotagliflozin) was initially rejected by the FDA in 2019 due to safety concerns, particularly the risk of diabetic ketoacidosis.

Resubmission Plans:
Despite the initial rejection, Lexicon plans to resubmit its application for Zynquista by mid-2024, aiming for approval as an add-on to insulin therapy for adults with Type 1 diabetes mellitus and chronic kidney disease.

European Approval:
Zynquista was approved in Europe in 2019, despite the FDA's rejection.

Other Indications:
The drug has been approved for heart failure under the brand name Inpefa and is being tested for hypertrophic cardiomyopathy.

Advisory Committee Meeting:
The FDA's scrutiny of Zynquista comes ahead of an advisory committee meeting, which will discuss the drug's safety and efficacy.

Previous Partnerships:
Sanofi was initially partnered with Lexicon on Zynquista but dropped out after the FDA rejection and trial failures in Type 2 diabetes.