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The US Food and drug Administration (FDA) has approved a drug to treat obesity for the first time in 13 years. Lorcaserin, marketed by Belviq, is made by Arena Pharmaceuticals.
“The US Food and Drug Administration today approved Belviq (lorcaserin hydrochloride), as an addition to a reduced-calorie diet and exercise, for chronic weight management,” it said in a statement.
The drug works to control the appetite through receptors in the brain by activating the serotonin 2C receptor.
Trials showed the drug helped patients lose an average of three to 3.7 per cent of their body weight after a year when compared to a placebo, the FDA said.
It is approved for use in obese adults with a body mass index of 30 or greater, or overweight adults with a BMI of 27 or greater who have at least one weight-related condition such as high blood pressure, type 2 diabetes, or high cholesterol.
“Obesity threatens the overall well-being of patients and is a major public health concern,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.
“The approval of this drug, used responsibly in combination with a healthy diet and lifestyle, provides a treatment option for Americans who are obese or are overweight and have at least one weight-related comorbid condition.”
The last anti-obesity drug approved in the United States was Xenical (Orlistat) by Roche in 1999.
Sold over the counter as Alli by GlaxoSmithKline, it works by preventing the body from absorbing fat, though its tendency to cause gastrointestinal side effects such as oily, loose stools have curbed its popularity among patients.
The FDA said it would require Arena Pharmaceuticals - which has offices in San Diego, California and Zofingen, Switzerland - to conduct six future post-marketing studies to assess risks such as heart attack and stroke.
The label will also recommend that Belviq be discontinued in patients who fail to lose five percent of their body weight after 12 weeks of treatment.
“These patients are unlikely to achieve clinically meaningful weight loss with continued treatment,” said the FDA statement.
Belviq should not be used by pregnant women and may cause serious side effects of taken in combination with certain medications for depression and migraine that increase serotonin levels or activate serotonin receptors.
“Belviq may also cause disturbances in attention or memory,” said the FDA.
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