FDA Approves Sanofi Aventis's Lantus
Lantus (insulin glargine) is a man-made form of a natural hormone.
It is a long-acting insulin that is slightly different from other forms of insulin that are not man-made and it works by lowering levels of glucose in the blood.
Lantus is used to treat type 1 (insulin-dependent) or type 2 (non insulin-dependent) diabetes.
LANTUS is indicated for once-daily subcutaneous administration for the treatment of adult and pediatric patients with type 1 diabetes mellitus or adult patients with type 2 diabetes mellitus who require basal (long-acting) insulin for the control of hyperglycemia.
Lantus® (insulin glargine [rDNA origin] injection) is a new true once a day background insulin from Aventis Pharmaceuticals. It represents a remarkable breakthrough in that it is the first insulin to offer truly flat insulin levels through the entire day for most users. It can be used by people with Type 1 or Type 2 diabetes who are six years old or older. Considered an alternative to an insulin pump, it is the first long-term insulin that has a predictable and consistent insulin activity.
Lantus is the first FDA approved long-acting (basal) recombinant human insulin analog with a once-daily administration and a 24-hour glucose-lowering effect. This biosynthetic insulin, injected subcutaneously and designed to mimic NPH human insulin, is indicated for both adult and pediatric patients with Type 1 diabetes. It may also be used for the treatment of adults with Type 2 diabetes who require basal insulin for the control of hyperglycemia.
The chemical structure of Lantus allows for regulated release of the insulin into the circulation with a glucose-lowering effect over a 24-hour period. In clinical studies, no specific pronounced peak was detected over this period.