SAXENDA® (LIRAGLUTIDE) INJECTION

This is a summary of the European public assessment report (EPAR) for Saxenda. It explains how the Agency assessed the medicine to recommend its authorization in the EU and its conditions of use. It is not intended to provide practical advice on how to use Saxenda. For practical information about using Saxenda, patients should read the package leaflet or contact their doctor or pharmacist.

WHAT IS SAXENDA AND WHAT IS IT USED FOR?

Saxenda is a medicine used along with diet and exercise to help manage weight in adults:

HOW IS SAXENDA USED?

Saxenda is available as a solution for injection in pre-filled pens. The medicine can only be obtained with a prescription. Saxenda is injected once per day, preferably at the same time every day. It is given as an injection under the skin in the thigh, upper arm or abdomen (belly). The starting dose is 0.6 mg per day. The dose is then increased each week by 0.6 mg to a maximum of 3.0 mg per day. Treatment with Saxenda should be stopped if patients have not lost at least 5% of their initial body weight after 12 weeks of treatment with 3 mg of Saxenda per day. The doctor should re-assess the need of continuing treatment once a year.

WHAT BENEFITS OF SAXENDA HAVE BEEN SHOWN IN STUDIES?

Saxenda has been shown to be effective at reducing body weight in 5 main studies involving over 5,800 obese or overweight patients and lasting up to 56 weeks, in which Saxenda was compared with placebo (a dummy treatment). Patients in the studies were given the medicine as part of a weight loss program involving counselling and advice on diet and exercise. Looking at the results of the 5 studies together, Saxenda at a daily dose of 3 mg led to a 7.5% reduction in body weight, compared with a 2.3% reduction in patients taking placebo. Patients treated with Saxenda had a continuous decrease in body weight during the first 40 weeks of treatment, after which the weight loss achieved was maintained. Weight loss was more pronounced in women than in men. When the figures for the main studies were re-analyzed using a more conservative method that assumed that patients who did not complete the study (around 30%) would not have seen any improvement, similar but smaller weight reductions with Saxenda were noted.