Sotagliflozin rejected by FDA; new lifestyle intervention guidelines

Sotagliflozin was not recommended for approval by the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee for glucose control as an adjunct to insulin in adults with type 1 diabetes and chronic kidney disease.

The committee voted 11-3 that the risks of sotagliflozin (Zynquista, Lexicon), especially for diabetic ketoacidosis, did not outweigh the benefits of glucose control it offered.

“I really feel like we need a prospective trial,” Cecilia C. Low Wang, MD, professor of medicine at University of Colorado Anschutz Medical Campus and member of the Glucose Management Team at University of Colorado Hospital, and chairperson of the committee, who voted no, said during the hearing.

“I have a really hard time voting to approve a drug when there are so little relevant data,” she added. “I feel like it does my patients a disservice.”

It was the top story in endocrinology last week.

In another top story, a novel clinical practice outline from the American College of Lifestyle Medicine outlines and recommends lifestyle interventions as the first line of defense for treating patients with prediabetes and type 2 diabetes.

Read these and more top stories in endocrinology below:

FDA panel votes against sotagliflozin for glucose control in type 1 diabetes, CKD

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee recommended not approving sotagliflozin for glucose control as an adjunct to insulin in adults with type 1 diabetes and chronic kidney disease. Read more.

‘This is the foundation’: New guideline emphasizes lifestyle-first approach to diabetes

A first-ever clinical practice guideline from the American College of Lifestyle Medicine outlines practical recommendations for lifestyle interventions as first-line therapy for people with prediabetes or type 2 diabetes. Read more.

Continuous glucose monitor sensors now approved to be worn during imaging procedures

Abbott announced that the FDA has removed the contraindication for its continuous glucose monitoring sensors to be used during imaging procedures. Read more.

Approaches to holistic obesity treatment and identifying healthful behaviors

Behavioral modification with diet and exercise demonstrated similar weight-loss benefits vs. other pharmaceutical and surgical approaches to obesity management, but patients must remain adherent, a speaker at the Cardiometabolic Health Congress reported. Read more.

GLP-1 use before weight-loss surgery rising, not linked to harmful outcomes

Among patients with obesity undergoing bariatric surgery, the proportion taking a GLP-1 receptor agonist in the year before their procedure rose sharply between 2018 and 2023, researchers reported. Read more.