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GEN News Highlights : May 24, 2012

FDA Clears Novo Nordisk’s Levemir for Diabetic Children Aged Two Years and Over

Approval means Levemir is the only basal insulin analog indicated for 2–5 year olds.

FDA approved Novo Nordisk’s long-acting Levemir® (insulin detemir [rDNA origin] injection) for the treatment of type 1 diabetes in patients aged 2–5 years. The drug is the only basal insulin analog indicated for use in young children, the firm points out.

Levemir is now approved for the treatment of type 1 diabetes in patients of all ages from 2 years and for treating type 2 diabetes in adults. In September 2011, EMA's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on the extended use of Levemir in type 1 diabetic children aged two to five years.

FDA clearance of the drug for 2–5 year-olds was based on clinical data in 82 patients, which demonstrated the therapeutic equivalence of Levemir to Neutral Protamine Hagedorn (NPH) insulin. Moreover, none of the patients receiving Levemir plus the firm’s rapid-acting insulin analog NovoLog® (insulin aspart [rDNA origin] injhection) experienced a severe hypoglycemic episode, whereas there were six reported episodes of severe hypoglycemia in three patients treated with NPH and NovoLog.

Levemir achieved sales of DKK 2.2 billion (about $375 million) in the first three months of 2012, up 24% on sales during Q1 2011. The firm’s diabetes franchise, which includes Victoza®, modern insulins (including Levmir, NovoRapid®, and NovoMix®), human insulins, oral antidiabetics, and protein-related products, achieved Q1 2012 sales of nearly DKK 13.9 billion (nearly $2.4 billion), up 18%.