FDA poised to discuss Victoza's cardiovascular benefit

A US Food and Drug Administration (FDA) advisory committee will next week discuss whether Victoza (liraglutide), the Novo Nordisk (NOV: N) GLP-1 agonist indicated for type 2 diabetes, can have cardiovascular safety added to its label.

On Tuesday, the Endocrinologic and Metabolic Drugs Advisory Committee will discuss the Danish firm’s application, and the results of the LEADER cardiovascular outcomes trial, ahead of the PDUFA date in August.

The editorial arm of the evaluate group,   EP Vantage notes that the FDA briefing papers published ahead of the meeting make it clear that there will be questions over how Victoza, the benefit of which was largely down to prevention of cardiovascular death, met the primary endpoint in the trial without showing a benefit on heart attacks and stroke, while with regards to safety, the papers consider that follow-up is needed to characterize the relationship between GLP-1s and the development of pancreatic cancer, a known risk factor with the class.