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PRINCETON, N.J. — The Food and Drug Administration has cleared Novo Nordisk to market its Levemir insulin for use in children ages two to five years with type 1 diabetes.
Novo Nordisk said Tuesday that with the expansion of its pediatric indication, Levemir (insulin detemir [rDNA origin] injection) is now available for type 1 diabetes patients from age 2 through adulthood and for adult patients with type 2 diabetes.
In addition, the company noted, the FDA approval makes Levemir the first and only basal insulin analog for use in this young patient group.
"Our biggest challenges and top priorities when treating some of the youngest children with type 1 diabetes are safety and reducing the risk of hypoglycemia," stated Dr. Mark Sperling, M.D., editor-in-chief of Pediatric Diabetes. "Levemir, with its approval from the FDA, is a particularly welcome addition to our treatment options for some of our youngest patients with type 1 diabetes."
A man-made long-acting insulin, Levemir is indicated for the management of high blood sugar in adults and children with diabetes mellitus.
Each year, more than 13,000 young people are diagnosed with type 1 diabetes, Novo Nordisk reported, and the youngest of those children have the greatest probability of severe hypoglycemia and the highest risk of acute diabetes complications.
