FDA expands Levemir use to young children; negative on tafamidis

Denmark-based global insulin giant Novo Nordisk (NOV: N) says that the US Food and Drug Administration has approved Levemir (insulin detemir [rDNA origin] injection) for use in children aged two to five years with type 1 diabetes.

With the expansion of its pediatric indication, Levemir  is now available for type 1 diabetes patients from age two through adulthood and adult patients with type 2 diabetes. The FDA approval now also makes Levemir the first and only basal insulin analog for use in this young patient group. Novo Nordisk’s mainstay modern insulin products, including Levemir (insulin detemir) and NovoRapid (insulin aspart) contributed 7.86 billion kroner ($1.35 billion) to first-quarter 2012 sales, a year-on-year increase of 17%.

"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," said Mark Sperling, editor-in-chief of Pediatric Diabetes, adding: "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."