Novo Nordisk applies to include new clinical data in Victoza labelling

Novo Nordisk has announced the submission of new applications to regulatory authorities to update the labelling for its diabetes therapy Victoza.

The company is seeking to include information from the LEADER cardiovascular outcomes trial in the product information of Victoza, in order to demonstrate the heart health benefits associated with the drug.

In the LEADER study, Victoza was shown to significantly 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.

The company has now filed a supplemental new drug application to the US Food and Drug Administration and a type II variation application to the European Medicines Agency to ensure the Victoza labelling reflects this.

Mads Krogsgaard Thomsen, executive vice-president and chief science officer of Novo Nordisk, said: "Reducing the risk of cardiovascular death in people with type 2 diabetes remains a significant unmet need and it is encouraging that we now have the opportunity to help address this challenge."

Victoza was approved in the EU in 2009 and is commercially available in more than 85 countries. It is now used to treat more than one million people with type 2 diabetes globally.

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.