In November 2024, an FDA advisory committee said the benefits of sotagliflozin do not outweigh the risks in adults with type 1 diabetes and chronic kidney disease.
The data, published in JASN, were presented last week to an FDA advisory committee considering recommending sotagliflozin as an adjunct to insulin in adults with T1D and CKD.
Novo Nordisk plans to file for regulatory approval this year of an expanded label for oral semaglutide, with an indication for reduction of MACE in high-risk adults with T2D.