Novo Nordisk Inc. received an approval from the US Food and Drug Administration for Levemir (insulin detemir [rDNA origin] injection) for the treatment of diabetes mellitus (type 1 and type 2). 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.
"Experts agree there is a significant need for consistent good control of patients' glucose levels, which is associated with a reduced risk of diabetes complications. The results seen to date with Levemir affirm the value that the product will provide to patients who struggle to manage their diabetes," said Peter Aurup, vice president of the clinical development, medical, and regulatory affairs department.
Additionally, a new drug application (NDA) for Levemir for paediatric 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). One study, a treat-to-target efficacy study of 475 patients using Levemir or NPH insulins, showed that patients on Levemir had mean A1C levels at the end of the study of approximately 6.6 percent, which meets the target level recommended by the American Diabetes Association, claims a company release.
Levemir is indicated for once- or twice-daily subcutaneous injection, epending 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.