Novo Nordisk has 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, (although not as first line therapy) and in combination with commonly prescribed oral medications for diabetes.
In Europe, EU Commission granted marketing authorisation for liraglutide on 30 June 2009, for all 27 European Union member states.2 It has been on the market in the UK since 7 July 2009. According to the EU authorisation, liraglutide is indicated for the treatment of adults with type 2 diabetes mellitus to achieve glycaemic control in combination with: Metformin or a sulphonylurea in patients with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin or sulphonylurea, and Metformin and a sulphonylurea or metformin and a thiazolidinedione in patients with insufficient glycaemic control despite dual therapy.
“The US approval of liraglutide represents 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 liraglutide will prove to be a valuable treatment option for people with type 2 diabetes in the US.”
Novo Nordisk expects to introduce Victoza in the US market within weeks.
Clinical results: LEAD (Liraglutide Effect and Action in Diabetes) The liraglutide phase 3 clinical trial programme, entitled LEAD, which formed the basis of the regulatory submission, is comprised of randomised studies comparing liraglutide to commonly prescribed treatments. These multinational trials evaluated liraglutide 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.
Furthermore, in addition to its glucose lowering effects, liraglutide is not associated with weight gain. For most patients with type 2 diabetes, clinical trial data demonstrate a reduction in body weight (between 1 and 2.8kg) in the LEAD programme. Body weight was a secondary endpoint in the clinical development trials.
The most common adverse events reported during the clinical development programme in patients treated with liraglutide were associated with the gastrointestinal system.
Gastrointestinal adverse events, including nausea, vomiting and diarrhoea were reported most frequently in the early part of the treatment period with liraglutide and lead to withdrawal from the trial in up to 2.8% of the patients.
Important safety information
The US prescribing information includes a boxed warning for the risk of thyroid c-cell tumours. In preclinical testing, liraglutide caused thyroid c-cell tumours in rodents. In clinical trials there were no reported cases of medullary thyroid carcinoma (MTC) in patients treated with liraglutide, but human relevance of the rodent findings could not be ruled out by clinical or nonclinical studies. Liraglutide is contraindicated in patients with a personal or family history of MTC or Multiple Endocrine Neoplasia syndrome type 2.
The marketing authorisation further includes a risk evaluation and mitigation strategy (REMS) programme comprised of a Medication Guide to patients and a Communication Plan directed at healthcare providers ” both informing about the risk of pancreatitis and the potential risk of MTC.