EMA recommends approval of liraglutide as weight loss drug

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.



Last updated
The Pharmaceutical Journal, EMA recommends approval of liraglutide as weight loss drug;Online:DOI:10.1211/PJ.2015.20067700

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