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Novo Nordisk receives approval for Levemir(R) in Japan (22 Oct 2007) |
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23 Oct 2007 |
Novo Nordisk expects to launch Levemir® in Japan in its prefilled FlexPen® device and in Penfill® for its NovoPen® injection systems before the end of 2007
BAGSVAERD, Denmark | October 22, 2007 | Novo Nordisk today announces that the Japanese Ministry of Health, Labour and Welfare has approved Levemir® (insulin detemir), the company’s long-acting modern insulin for use in type 1 and type 2 diabetes including combination treatment with oral antidiabetics (OADs).
Novo Nordisk expects to launch Levemir® in Japan in its prefilled FlexPen® device and in Penfill® for its NovoPen® injection systems before the end of 2007. With the new approval, Novo Nordisk will be the only company in Japan offering rapid-acting, pre-mixed as well as long-acting modern insulins, allowing doctors and patients to tailor insulin regimens to each patient’s individual needs.
“Diabetes is a large and growing public health issue in Japan. With the launch of Levemir®, we are providing an improved basal insulin, which we believe will benefit many patients,” said Kåre Schultz, chief operating officer of Novo Nordisk.
It is estimated that diabetes currently affects more than 16 million people in Japan; 7.4 million have diabetes or glucose levels indicating diabetes, and 8.8 million have pre-diabetes.[1]
Levemir® was approved in Europe in 2004 and in the US in 2005, and is currently marketed in 58 countries worldwide.
The approval of Levemir® in Japan does not change Novo Nordisk's expectations for the financial results for 2007.
About Levemir®
Levemir® is a long-acting modern insulin (insulin analogue) that covers the body’s basal insulin need. Levemir® is released gradually and therefore it entails less fluctuation in blood glucose levels and better predictability compared to traditional long-acting NPH insulins.[2] Levemir® in combination with OADs should be initiated with once-daily administration at a dose of 10 U or 0.1–0.2 U/kg and titrated based on individual patient needs.2 The dose should be taken in the evening, at dinner or before bedtime.[3] Injections can easily be managed with the FlexPen® prefilled insulin pen.[4],[5],[6]
References
[1] Health, Labour and Welfare Association, Ministry of Health: Annual Japanese Health, Labour and Welfare Statistics 2002
[2] Levemir®. Summary of Product Characteristics.
[3] Philis-Tsimikas A, et al. Comparison of once-daily insulin detemir with NPH insulin added to a regimen of oral antidiabetic drugs in poorly controlled type 2 diabetes. Clin Ther 2006; 28:1569–1581.
[4] IMS Health Worldwide Sales Data (July 2007).
[5] Niskanen L, et al. Randomized, multinational, open-label, 2-period, crossover comparison of biphasic insulin aspart 30 and biphasic insulin lispro 25 and pen devices in adult patients with type 2 diabetes mellitus. Clin Ther 2004; 26:531–40.
[6] Asakura T. Clin Ther/New Technology 2005; A2069-PO.
SOURCE: NOVO NORDISK |
