FDA Approves Levemir(R) (insulin detemir [rDNA Origin] Injection)

A New, Long-Acting Insulin Treatment for Diabetes. Denmark’s Novo Nordisk said on Friday the United States Food and Drug Administration (FDA) has approved its long-acting 24 hr. insulin for treatment of diabetes.

Levemir is a novel, long- acting form of insulin that provides up to a 24-hour duration of action and has been shown to cause little weight change.(1) Additionally, a New Drug Application (NDA) for Levemir for pediatric indication is currently under review by the FDA.

The safety and efficacy of Levemir given once or twice daily was compared to NPH human insulin or insulin glargine in controlled clinical studies involving a total of 6004 patients with diabetes (3724 with type 1, and 2280 with type 2). In one study, a treat-to-target efficacy study of 475 patients using Levemir or NPH insulins, 70 percent of those treated with Levemir achieved an A1C of approximately 6.6 percent, which meets the target level recommended by the American Diabetes Association. There was no significant difference between the two treatment arms. In other studies, Levemir achieved a level of glycemic control similar to that provided by other basal insulins, as measured by A1C.(2)

Levemir is indicated for once- or twice-daily subcutaneous injection, depending on blood glucose control and insulin requirements throughout the day. Levemir provides a relatively flat action profile. Levemir can be used in monotherapy, added to oral anti-diabetic agents, or used in combination with a rapid-acting insulin. Levemir has already been approved for use in 37 countries worldwide, including countries throughout Europe. As of January 2005, approximately 88,075 patients have been treated with Levemir.

Hypoglycemia is the most common adverse effect of insulin therapy, including Levemir. Adverse events commonly associated with human insulin therapy include allergic reactions, injection site reaction, lipodystrophy, pruritus, and rash. Levemir is contraindicated in patients hypersensitive to insulin detemir or its excipients.

(1) Levemir(R) (insulin detemir). Product information. Novo Nordisk Inc., Princeton, NJ. May, 2005. (2) Levemir(R) (insulin detemir). Diabetes Fact Sheet. Available at: https://www.cdc.gov/diabetes/pubs/pdf/ndfs_2003.pdf.

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