Novo Nordisk receives approval in the EU for use of NovoRapid® in elderly people

Novo NordiskNovo Nordisk today announced that the European Commission has approved the rapid-acting insulin NovoRapid® (insulin aspart) for treatment of diabetes in the elderly and in people with renal or hepatic impairment.

NovoRapid® has been available since 1999 and is to date the only rapid-acting, modern insulin to receive such an approval for use in elderly people. With this, NovoRapid® has been established as an insulin that is safe to use by all people from two years of age with types 1 or 2 diabetes[1].

"Diabetes is a progressive disease and as such, many older people with diabetes are requiring more intensive insulin therapy as time goes by," says Dr Tim Heise, MD, CEO – Clinical Science, one of the leading authors of the trials behind the approval.

"The trials we conducted in 2001 and 2002 showed that insulin aspart is absorbed rapidly and reaches peak activity in a short time in the elderly population[2], which should allow for a flexible treatment with improved meal-time coverage[3]. The new approval of insulin aspart provides a new treatment option for those patients who have difficulties in maintaining acceptable blood glucose levels around mealtimes with their current human insulin treatment," adds Dr Heise.

According to the International Diabetes Federation (IDF), approximately 20% of the world’s elderly population live with diabetes, and the figure is steadily increasing. Many older people with diabetes currently use human insulin, but with the efficacy and safety of NovoRapid® now documented specifically in the elderly, this presents a new and improved treatment option.

About NovoRapid®
NovoRapid® (insulin aspart) is a rapid-acting modern insulin, licensed in the EU for the treatment of type 1 and type 2 diabetes in children aged two years or older[4], pregnant women[5],[6], elderly2 and special populations with renal and hepatic impairment[7].

NovoRapid® can be injected immediately before or soon after a meal3 and is normally used in a basal/bolus combination regimen with a long-acting insulin such as Levemir® (insulin detemir).

NovoRapid® has a faster onset and shorter duration of action than soluble human insulin. It offers significant improvements in glucose control after a meal[8],[9] with significantly less incidence of nocturnal hypoglycaemia[10].

About Novo Nordisk
Novo Nordisk is a healthcare company and a world leader in diabetes care. The company has the broadest diabetes product portfolio in the industry, including the most advanced products within the area of insulin delivery systems. In addition, Novo Nordisk has a leading position within areas such as haemostasis management, growth hormone therapy and hormone replacement therapy. Novo Nordisk manufactures and markets pharmaceutical products and services that make a significant difference to patients, the medical profession and society. With headquarters in Denmark, Novo Nordisk employs approximately 25,350 employees in 79 countries, and markets its products in 179 countries. Novo Nordisk's B shares are listed on the stock exchanges in Copenhagen and London. Its ADRs are listed on the New York Stock Exchange under the symbol 'NVO'. For more information, visit www.novonordisk.com.

References
[1] Summary of Product Characteristics, NovoRapid®, September 2007.
[2] Krones R, et al. Time-action profiles of insulin aspart and human regular insulin in elderly and middle-aged subjects with Type 2 diabetes. Diabetologia 2004; 47 (Suppl 1):A266.
[3] Rosenfalck AM, et al. Improved postprandial glycaemic control with insulin Aspart in type 2 diabetic patients treated with insulin. Acta Diabetol 2000; 37:41–6.
[4] Mortensen HB, et al. Rapid appearance and onset of action of insulin aspart in paediatric subjects with type 1 diabetes. Eur J Pediatr 2000; 159:483–8.
[5] Hod, M, et al. Fetal and Perinatal Outcomes in Type 1 diabetes pregnancy: a randomized study comparing insulin aspart with human insulin in 322 subjects. Am J Obs Gyn 2007 (in press).
[6] Mathiesen ER et al. Maternal Glycemic Control and Hypoglycaemia in Type 1 Diabetic Pregnancy: a randomized trial of insulin aspart versus human insulin in 322 pregnant women. Diabetes Care 2007; 30:771–776.
[7] Holmes, G et al. Pharmcokinetics of insulin aspart in obesity, renal impairment, or hepatic impairment. Br J Clin Pharmacol 2005; 60:469–76.
[8] Brunner GA, et al. Post-prandial administration of the insulin analogue insulin aspart in patients with Type 1 diabetes mellitus. Diabet Med 2000; 17:371–375.
[9] Danne T, et al. A comparison of Postprandial and Pre-prandial Administration of Insulin Aspart in Children and Adolescents With Type 1 Diabetes. Diabetes Care 2003; 26:2359–2384.
[10] Heller S, et al. Hypoglycaemia with insulin aspart: a double blind, randomised, crossover trial in subjects with type 1 diabetes. Diabet Med 2004; 21:769–775.

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