After complete response letter, Lexicon triggers rarely used mechanism for formal hearing, prompting US FDA to publicly list its problems with the proposed type 1 diabetes drug, for which Sanofi had originally sought approval.
US FDA denied two formal requests for dispute resolution related to sotagliflozin after issuing a complete response letter to original application holder Sanofi . • Source: Shutterstock
Lexicon Pharmaceuticals, Inc. expects to request a formal hearing to overturn the US Food and Drug Administration’s rejection of sotagliflozin in type 1 diabetes, and clarify the product’s prospects in the disease.
The company is able to request a hearing with the FDA commissioner after a series of complete response letter appeals...
