New weight loss drug gets FDA nod
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The first new prescription diet pill in 13 years won approval from the Food and Drug Administration on Wednesday, providing a new option for roughly one-third Americans considered obese.
The new drug, developed by Arena Pharmaceuticals of San Diego, has been known as lorcaserin and will be sold under the name Belviq by Eisai Inc. Before Belviq's approval, only one anti-obesity medicine had been approved for long-term use — Roche's Xenical, which reached the market in 1999.
The history of diet pills has been marked by many safety problems, which has made the FDA reluctant to approve new drugs. Belviq itself was turned down by the agency in 2010, but Arena came back with new data that assuaged concerns.
Some patient advocates and doctors who treat obesity say there is a need for new medicines to help to plug a "treatment gap" between diet and exercise, which do not work for many people, and the more radical option of bariatric surgery. They say obesity itself is a serious disease that causes other health problems like diabetes and heart disease.
In announcing the approval of Belviq, the FDA suggested that it agreed with that point of view. "Obesity threatens the overall well being of patients and is a major public health concern," Dr. Janet Woodcock, director of the drug evaluation centre at the FDA, said.
Arena said it was not clear yet when the drug would be available.
Belviq provides only modest weight loss. In the two main clinical trials, those who took the drug lost an average of 5.8 per cent of their weight after a year, while those using a placebo lost 2.5 per cent. However, some 23 per cent of the patients using Belviq lost at least 10 per cent of their body weight. Taken twice a day, Belviq activates a receptor in the brain, called serotonin 2C, in a way that makes people feel full.
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