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news.The FDA has granted marketing authorisation to Novo Nordisk for Victoza for the treatment of type 2 diabetes in adults. Victoza is the brand name approved in the US and Europe for liraglutide, a once-daily human Glucagon-Like Peptide-1 (GLP-1) analogue, developed for the treatment of type 2 diabetes. Novo Nordisk expects to introduce Victoza in the US market within weeks.
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In the US, Victoza is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes. This provides for Victoza to be used in monotherapy, as second-line treatment and in combination with commonly prescribed oral medications for diabetes.
The Victoza phase 3 clinical trial programme, entitled Lead, which formed the basis of the regulatory submission, is comprised of randomised, controlled, double-blinded studies comparing Victoza to commonly prescribed treatments.
Reportedly, these multinational trials evaluated Victoza in monotherapy as well as in combination with one or two oral antidiabetic medications and showed better or equivalent lowering of blood glucose than active comparators, such as sulphonylureas and thiazolidinediones.
The company claims that unlike many other diabetes medications, Victoza is not associated with weight gain. For patients with type 2 diabetes, clinical trial data demonstrate a reduction in body weight in the Lead programme. Body weight was a secondary endpoint in the clinical development trials.
Lars Rebien Sorensen, president and CEO of Novo Nordisk, said: “The US approval of Victoza represents a major advancement in the treatment of type 2 diabetes and is an important milestone for Novo Nordisk that follows the recent approval in Japan and the ongoing successful launch in Europe.
“We are convinced that Victoza will prove to be a valuable treatment option for people with type 2 diabetes in the US. The ability of Victoza to substantially improve glucose control with a low risk of hypoglycaemia creates an opportunity for more patients with type 2 diabetes to achieve their individual treatment goals.”