Novo Nordisk is celebrating after winning US Food and Drug Administration approval for Levemir (insulin detemir) – a long-acting insulin analog for the treatment of diabetes.
Levemir has already been approved for use in 37 countries around the world, including countries throughout Europe [[07/06/04e]], and an application for paediatric approval is currently under review by the FDA.
The firm says that the product leads to a more predictable day-to-day profile of action, compared to available products. The firm also notes that its drug is associated with a lower risk of nocturnal hypoglycaemia and lower fasting plasma glucose in long-term clinical trials. Levemir also showed the added benefit of no weight gain, compared to standard insulin.
