Liraglutide Gets Okay From EU for Obesity

January 23, 2015

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of liraglutide (Saxenda, Novo Nordisk) for weight loss.

The agent, an injectable glucagonlike peptide (GLP-1) agonist, is already approved as Victoza for the treatment of type 2 diabetes.

In obesity, liraglutide is used at a higher dose (3 mg per day) than in diabetes (up to 1.8 mg per day), and the EU green light for this new indication comes within a month of the US Food and Drug Administration also approving it for this use.

If marketing authorization is granted, which is normally a formality within 2 months, liraglutide will join prolonged-release naltrexone/bupropion (Orexigen Therapeutics/Takeda), which was recommended for approval by the European authorities in December, as one of the first new agents for weight loss in the European Union for many years.

Once available, these new agents will be welcomed as an option by doctors treating obesity in Europe, who have long bemoaned the fact that they have not had access to any of the newer agents for weight loss that have been available in the United States. However, reimbursement will undoubtedly be an issue in some EU countries.

"Once marketing authorization 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," the EMA notes in a statement.

Liraglutide will be indicated for use in adults with a body mass index (BMI) of 30 kg/m2 or greater (obese), as well as in 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 apnea. The medicine is recommended for use in addition to a reduced-calorie diet and physical activity.

"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 EMA says.

The effectiveness of liraglutide for weight loss was shown in five clinical trials involving around 5800 obese or overweight patients, which showed that more patients given liraglutide achieved clinically relevant weight loss than those treated with placebo.

The CHMP recommends that patients started on liraglutide for weight loss should be evaluated after 12 weeks of treatment with 3 mg/day. If a patient has not lost at least 5% of their initial body weight by this time, treatment 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, the EMA notes.

"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," it observes.


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