Novo Nordisk announced that the US Food and Drug Administration (FDA) has granted marketing authorisation for Victoza for the treatment of type 2 diabetes in adults.
Victoza? is the brand name approved in the US and Europe for liraglutide, the first once-daily human Glucagon-Like Peptide-1 (GLP-1) analogue developed for the treatment of type 2 diabetes.
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 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.” says Lars Rebien S?rensen, president and CEO. “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.”
Novo Nordisk expects to introduce Victoza? in the US market within weeks.
Source: Novo Nordisk, USA