Synthetic Insulin Approved by FDA

The U.S. Food and Drug Administration has approved Lantus (insulin glargine [rDNA origin] injection) by Aventis Pharmaceuticals for the treatment of type 2 and type 1 diabetes.

Lantus is indicated for subcutaneous administration once a day at night for the treatment of adult patients with type 2 diabetes mellitus who require long-acting insulin for the control of hyperglycemia and also for pediatric and adult patients with type 1 diabetes mellitus.

Lantus provides a relatively constant concentration/time profile over a 24-hour period with just one administration a day, according to a company press release.

Lantus is a recombinant human insulin analog. The biosynthetic product closely resembles human insulin. The chemical structure of Lantus regulates its release from the tissue into the circulation, which helps it provide a constant concentration profile with no pronounced peak with a glucose-lowering effect over a day.

Lantus demonstrated similar levels of efficacy in regards to metabolic control as NPH human insulin in controlled clinical trials, according to the company.

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