Top stories in endocrinology: FDA recommends approval of romosozumab for osteoporosis, 'Simple 7' CV health factors associated with lower diabetes risk

Among the top endocrinology stories last week were the FDA recommending approval of romosozumab for the treatment of osteoporosis in postmenopausal women at high risk for fracture and a study that found adherence to the American Heart Association’s “Simple 7” cardiovascular health components was associated with lower diabetes risk in adults with normal glucose tolerance.

Other highlights include the FDA advisory committee tying in its vote to approve a dual SGLT inhibitor for type 1 diabetes, a study that found cholesterol levels can be affected by meal timing, and findings that suggested higher levels of HbA1c do not influence the risk for end-stage kidney disease and death in adults with diabetes.

FDA advisory committee recommends approval of romosozumab for osteoporosis

The Bone, Reproductive and Urologic Drugs Advisory Committee of the FDA voted 18-1 Wednesday in favor of recommending approval of a biologics license application for the monoclonal antibody romosozumab for the treatment of osteoporosis in postmenopausal women at high risk for fracture, with two of 18 “yes” votes supporting a different indication for the drug. Read more.

‘Simple 7’ CV health components associated with lower diabetes risk for adults with normal glucose tolerance

Among healthy adults with normal glucose tolerance, adherence to four or more cardiovascular health factors proposed by the American Heart Association was associated with an 80% lower risk for developing diabetes over 10 years, according to findings published in Diabetologia. Read more.

FDA advisory committee splits vote recommending dual SGLT inhibitor for type 1 diabetes

The Endocrinologic and Metabolic Drugs Advisory Committee voted 8-8 in a decision on whether to recommend approval of a new drug application for oral sotagliflozin, a first-in-class dual SGLT1 and SGLT2 inhibitor for type 1 diabetes, with several members expressing concerns about an observed risk in diabetic ketoacidosis and calling for a risk evaluation and mitigation strategy if the therapy is approved. Read more.

Meal timing may affect cholesterol levels

LDL cholesterol levels can be lowered by eating less at night and shifting late-evening fat intake to earlier in the day, according to findings published in Nutrition, Metabolism & Cardiovascular Diseases. Read more.

End-stage kidney disease risk in diabetes not influenced by elevated HbA1c

Higher levels of HbA1c do not increase the composite risk for end-stage kidney disease and death in adults with diabetes, according to findings published in the Journal of Diabetes and its Complications. Read more.