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Medicines licensing

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.

 

 

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2015.20067700

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