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The US Food and Drug Administration has approved the use of Novo Nordisk's Levemir basal insulin for type 1 children aged two to five years. The FDA decision makes Levemir (insulin detemir [rDNA origin]) the only basal insulin approved for use in this age group.
Levemir, introduced to the US market in 2006, was previously approved for older children and adults with type 1 diabetes, as well as insulin-using type 2s.
The new FDA approval was based on Levemir's performance in reducing the risk of severe hypoglycemic episodes in the two-to-five year age group. Type 1 children in that group who received Levemir and a rapid-acting insulin analog, NovoLog (insulin aspart [rDNA origin] injection), experienced a lower rate of hypoglycemia than those taking NPH and NovoLog. None of the young patients treated with Levemir had a severe hypoglycemic episode, whereas six episodes were reported in three patients treated with NPH over the one-year study period.
Source: Novo Nordisk press release
0 comments - Jun 7, 2012