The European Medicines Agency (EMA) is recommending that the prescription-only injectable drug liraglutide (Saxenda) should be granted a marketing authorisation as a weight loss product.
It should only be offered to adults who have a body mass index of more than 30 or between 27 and 30 if they also have a weight-related condition such as type 2 diabetes, high blood pressure, high cholesterol or obstructive sleep apnoea. Patients should also be following a reduced-calorie diet and taking part in physical activity, according to the EMA’s Committee for Medicinal Products for Human Use (CHMP).
The CHMP is recommending patients receive a daily 3mg dose and be evaluated after 12 weeks. Treatment should be stopped if body weight has not reduced by at least 5% within that timescale.
Liraglutide is a glucagon-like-peptide-1 (GLP-1) receptor agonist; it is currently approved in lower doses across Europe for the treatment of type 2 diabetes.
The EMA says the mechanism triggered by liraglutide that results in weight loss is not entirely understood but it appears to regulate the appetite by inducing a feeling of fullness and reducing hunger pains.
The CHMP recommendation still has to be endorsed by the European Commission and comes a month after the US Food and Drug Administration approved the weight loss product for use in the United States.