Novo Nordisk's diabetes drug Victoza gets European OK

Novo Nordisk has been boosted by the news this morning that its diabetes drug Victoza has been approved by regulators in Europe.

The Danish drugmaker says that the European Commission has granted marketing authorisation for Victoza (liraglutide), a move which Novo says is an "important milestone". The drug is the first once-daily human glucagon-like peptide-1 (GLP-1) analogue for the treatment of type 2 diabetes and the approval allows Victoza to be used in combination with metformin and/or a sulphonylurea, or in combination with metformin and a thiazolidinedione, in patients who achieve insufficient glycaemic control with specified prior therapies.

Mads Krogsgaard Thomsen, Novo’s chief science officer. Noted that in clinical studies involving more than 6,500 people with type 2 diabetes, Victoza has been shown to have a significant blood glucose-lowering effect and lead to weight loss, while having a low risk of hypoglycaemia. “On this background, we are convinced that Victoza is a valuable new treatment option,” he added.

Novo will launch Victoza in the UK, Germany and Denmark during the summer and in other European markets during the second half of the year and throughout 2010. It is in the same class as Amylin/Eli Lilly’s blockbuster Byetta (exenatide) and Novo has presented data which shows that liraglutide provides statistically significantly better blood glucose control than exenatide. It also requires one injection per day, instead of two.

The pathway to approval in the USA looks a bit trickier because in April, the Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee voted 8-5 that there is sufficient clinical data for liraglutide, to rule out “excess cardiovascular risk relative to competitors". However, the panellists were split (6-6, with one abstention) as to whether data on thyroid tumours seen in studies on rodents permit approvability.