Novo Nordisk receives CHMP backing for Tresiba label update

Novo Nordisk has announced that its diabetes therapy Tresiba has had a proposed label update recommended by Europe's Committee for Medicinal Products for Human Use (CHMP).

The European Medicines Agency committee has issued a positive opinion endorsing an update of the label for Tresiba to include data from the SWITCH 1 and 2 clinical trials. Following this, updated marketing authorisation is expected in the second quarter of 2017.

In these trials, the new-generation once-daily basal insulin demonstrated clinically relevant reductions in hypoglycaemia compared with insulin glargine U100 in people with type 1 and type 2 diabetes.

Including the SWITCH trial results on the label will further strengthen the clinical profile of Tresiba, which is designed to offer a duration of action that lasts beyond 42 hours thanks to a flat and stable glucose-lowering effect.

Mads Krogsgaard Thomsen, executive vice-president and chief science officer at Novo Nordisk, said: "Following the submission of the application to the European Medicines Agency in November 2016, we are very pleased to have received a positive opinion from the CHMP for the label update already at this point in time."

To date, Tresiba has been launched commercially in more than 50 countries.

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.