The US FDA has granted marketing authorisation for Novo Nordisk's Levemir, long-acting insulin analogue for the treatment of diabetes. With the US approval of Levemir, Novo Nordisk is the only company in the US with a complete range of insulin analogues, encompassing rapid-acting NovoLog, premixed NovoLog Mix 70/30 and now also the long-acting analogue Levemir, according to a company release.
In addition to the US approval, Levemir has already been approved for use in 37 countries, including the countries in the European Union. The product has been introduced in 11 European markets, with additional launches expected during the second half of 2005.
Levemir is indicated for once or twice-daily subcutaneous administration in the treatment of adult patients with diabetes mellitus who require basal (long-acting) insulin for the control of hyperglycaemia. Levemir can be used as the basal component of basal-bolus therapy in type 1 and type 2 diabetes and as add-on therapy in people with type 2 diabetes who are inadequately controlled on oral antidiabetic agents. The file on use in paediatrics is under review with the FDA and a decision is expected before the end of 2005, the release said.
"The US approval of Levemir is an important event for Novo Nordisk in the US as it completes our portfolio of insulin analogues and thereby paves the way for continued expansion of our US diabetes care franchise," says Kare Schultz, executive vice president and chief operating officer.
Novo Nordisk expects to introduce Levemir in the US market within the next 12 months.