The FDA has approved Lantus (insulin glargine [rDNA origin] injection) for the treatment of type 2 and type 1 diabetes, the first long-acting recombinant human insulin analog with once-daily administration and 24-hour glucose-lowering effect to be approved by the FDA. Aventis Pharmaceuticals, the U.S. pharmaceutical arm of Aventis Pharma AG, plans to have the product available for patients later this year.
Lantus is indicated for once-daily subcutaneous administration at bedtime in the treatment of adult patients with type 2 diabetes who require basal (long-acting) insulin for the control of hyperglycemia and for adult and pediatric patients with type 1 diabetes.
A recombinant human insulin analogue, in clinical trials Lantus demonstrated similar levels of efficacy, in regard to metabolic control, as NPH human insulin. In clinical studies, Lantus showed a slower, more prolonged absorption, Aventis said, and a relatively constant concentration/time profile over 24 hours with no pronounced peak in comparison to NPH human insulin.
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