Novo Nordisk receives positive opinion on Levemir from EU committee
The EU\'s Committee for Proprietary Medicinal Products (CPMP) has adopted a positive opinion, recommending granting marketing authorisation to Novo Nordisk for Levemir (insulin detemir), a long-acting insulin analogue for the treatment of diabetes.
The EU's Committee for Proprietary Medicinal Products (CPMP) has adopted a positive opinion, recommending granting marketing authorisation to Novo Nordisk for Levemir (insulin detemir), a long-acting insulin analogue for the treatment of diabetes.
Following the positive opinion from CPMP, Novo Nordisk anticipates that the European Commission will issue marketing authorisation for Levemir in the EU within the coming months. Subsequent to the marketing authorisation Novo Nordisk expects to launch Levemir in key European markets in the second half of 2004.
Levemir is said to provide more consistent day-to-day control of blood glucose levels compared to conventional insulin preparations. Among the benefits for people with diabetes, it has been demonstrated that Levemir reduces fasting blood glucose and the risk of hypoglycaemia, especially at night-time. In addition, studies have shown that people using Levemir do not experience the undesirable weight gain often associated with conventional insulin preparations.