Novo Nordisk’s Victoza earns CHMP backing for label update

Novo Nordisk has announced that its diabetes drug Victoza has received a recommendation for approval of a new label update.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion on an update to the EU label for Victoza that would reflect the results of the recent LEADER trial.

In this study, it was demonstrated that Victoza is able to reduce the risk of cardiovascular death, non-fatal myocardial infarction and non-fatal stroke by 13 percent versus placebo, when added to standard of care among type 2 diabetes patients.

As such, the label update would reflect both glycaemic control and cardiovascular events as integral parts of type 2 diabetes treatment.

Mads Krogsgaard Thomsen, executive vice-president and chief science officer of Novo Nordisk, said: "There remains an unmet medical need to further reduce cardiovascular risk in people with type 2 diabetes, and we are very pleased that the CHMP has recommended the Victoza label update based on the LEADER trial."

Novo Nordisk now expects to receive a final European Commission decision for the Victoza label update in the third quarter of 2017.

With over 20 years of experience within the pharmaceutical market, we at Zenopa have the knowledge, skills and expertise to help find the right job for you. To find out more about the current pharmaceutical roles we have available, you can search for the latest job roles, register your details, or contact the team today.