New anti-obesity drug recommended in Europe
A high dose form of liraglutide has been backed by the CHMP
The European Medicines Agency has recommended granting a marketing authorisation for liraglutide (Saxenda, Novo Nordisk) for weight management in overweight or obese adults.
The medicine is recommended for use in addition to a reduced-calorie diet and physical activity.
Liraglutide, a high dose version of the current NICE-recommended treatment Victoza for type 2 diabetes, provides a treatment option for adults with a body mass index (BMI) of 30 kg/m2 or greater, as well as adults with a BMI of 27 kg/m2 to <30 kg/m2, who also have one or more complications related to their weight, such as type 2 diabetes, high blood pressure, high cholesterol or obstructive sleep apnoea.
Its mechanism of action is a glucagon-like peptide-1 (GLP-1) receptor agonist. The intended dose for its use in weight management is 3mg to be administered as an injection once a day. Its active substance, liraglutide, is currently approved in the European Union under the trade name Victoza for the treatment of type 2 diabetes at lower doses up to 1.8mg per day.
Liraglutide belongs to a different pharmacological class than other weight management products currently available in the EU, such as high dose forms of orlistat.
The mechanism by which liraglutide treatment results in weight loss is not entirely understood but it appears to regulate the appetite by increasing feelings of fullness and lowering feelings of hunger.
The effectiveness of the drug was shown in five clinical trials involving around 5 800 obese or overweight patients, which showed that more patients given liraglutide achieved clinically relevant weight loss than those treated with placebo.
All patients enrolled in these trials also received counselling on diet and physical activity.
The Committee for Medicinal Products for Human Use (CHMP) recommended that patients started on the drug should be evaluated after 12 weeks of treatment with 3mg of liraglutide per day.
If a patient has not lost at least five per cent of their initial body weight by this time, treatment with the drug should be stopped.
GLP-1-based therapies may cause an increased heart rate and there have also been a small number of reports of acute pancreatitis, as well as gallstones and inflammation of the gallbladder.
These concerns will be closely monitored as part of the risk management plan for the treatment, according to the EMA. In addition, safety monitoring for Saxenda will also benefit from information that is collected for Victoza.
The CHMP opinion will now be sent to the European Commission for the adoption of a decision on EU-wide marketing authorisations, which usually takes around three months.