Nephrology

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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.

The FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 11 to 3 against recommending the SGLT1/SLGT2 inhibitor to treat adults with T1D and CKD.

Your daily dose of the clinical news you may have missed.

In a post hoc analysis of the SCORED trial, investigators observed positive renal protection with sotagliflozin across a spectrum of baseline kidney function and glycemic control.

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.

Lexicon's sotagliflozin is on the October 31 docket for discussion by the FDA's Endocrinologic and Metabolic Drugs Advisory Committee; PDUFA goal date remains set for December 20.

Today, nearly 37 million Americans have chronic kidney disease (CKD), yet only about one percent of those Americans are even aware of their disease. And access to care is under threat.

Your daily dose of the clinical news you may have missed.