Medicine to be used in addition to reduced-calorie diet and physical activity
The European Medicines Agency has recommended granting a marketing authorisation for Saxenda (liraglutide) for weight management in overweight or obese adults. The medicine is recommended for use in addition to a reduced-calorie diet and physical activity.
The medicine, which will only be available on prescription, provides a treatment option for adults with a body mass index (BMI) of 30 kg/m2 or greater (obese), as well as adults with a BMI of 27 kg/m2 to <30 kg/m2 (overweight) 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.
Obesity is one of the most significant public health challenges globally and being overweight or obese is a major risk factor for a number of chronic diseases, including diabetes and cardiovascular disease.
Saxenda is a glucagon-like peptide-1 (GLP-1) receptor agonist. The intended dose for its use in weight management is 3 mg to be administered as an injection once a day. Its active substance, liraglutide, is currently approved in the European Union (EU) under the trade name Victoza for the treatment of type 2 diabetes at lower doses up to 1.8 mg per day.
Liraglutide belongs to a different pharmacological class than other weight management products currently available in the EU. 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 Saxenda was shown in five clinical trials involving around 5,800 obese or overweight patients, which showed that more patients given Saxenda achieved clinically relevant weight loss than those treated with placebo (a dummy treatment). All patients enrolled in these trials received counselling on diet and physical activity.
The Committee for Medicinal Products for Human Use (CHMP) recommended that patients started on Saxenda should be evaluated after 12 weeks of treatment with 3 mg of Saxenda per day. If a patient has not lost at least five per cent of their initial body weight by this time, treatment with Saxenda should be stopped. The product information for this medicine provides advice on the safe use of the product.
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 Saxenda. In addition, safety monitoring for Saxenda will also benefit from information that is collected for Victoza.
The applicant received scientific advice from the CHMP which pertained to clinical aspects of the dossier.
The opinion adopted by the CHMP at its January 2015 meeting is an intermediary step on Saxenda’s path to patient access. The CHMP opinion will now be sent to the European Commission for the adoption of a decision on EU-wide marketing authorisations. Once marketing authorisation has been granted, a decision about price and reimbursement will then take place at the level of each Member State considering the potential role/use of this medicine in the context of the national health system of that country.
Posted on the EMA website on 23 January 2015