Novo Nordisk's diabetes drug recommended for expanded indication in Europe

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has given its recommendation to expand the indication of Novo Nordisk’s diabetes therapy Victoza (liraglutide) to cover glycaemic control and the risk reduction of cardiovascular (CV) events.   

The decision was based on results of the LEADER trial, which found that, when added to standard of care in type 2 diabetes treatment, Victoza lowered the risk of CV death and non-fatal stroke or heart attack by 13% compared to placebo. This means the drug is the only approved GLP-1 receptor agonist to provide such reductions in major CV event risk in this indication.

“There are an estimated four million people living with type 2 diabetes in the UK3 and CV disease is the leading cause of death within this community4” said Professor Steve Bain, who acted as National Leader on the LEADER trial, and serves as Assistant Medical Director for Research & Development for ABM University Health Board and Clinical Lead for the Diabetes Research Unit in Wales. “The CHMP positive opinion is a welcomed step forward to help address the unmet medical need of reducing CV risk in people living with type 2 diabetes. It further reinforces the importance of broader diabetes management, looking at glucose control but also considering other prevalent and potentially serious comorbidities.”

Dr Avideh Nazeri, Director of Clinical, Medical and Regulatory, UK and Ireland at Novo Nordisk added: “We are very pleased with the CHMP positive recommendation to expand the indication for liraglutide. Optimum patient care is at the heart of Novo Nordisk’s values, so expanding treatment options for patients, particularly ones that have the potential to reduce CV risk, is very positive. Clinical practice in diabetes is evolving, from glycaemic centric management to a multifactorial approach, and having treatment options available to reflect both patient and clinical needs would be important.”

The CHMP’s positive opinion will now be referred to the European Commission for a final verdict on whether the drug will be made available within the EU – a decision is expected in the third quarter of this year.

Matt Fellows