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lorcaserin成为13年来首个在美国获批的肥胖症治疗药物

来源:环球医学编译    时间:2012年06月29日    点击数:    5星

6月29日消息 - 环球医学据悉,本周三(2012年6月27日),由Arena制药公司生产的药物lorcaserin(商品名为Belviq)获得了美国食品和药物管理局(FDA)的批准,成为了13年来首个获批的肥胖症治疗药物。

FDA在一份声明中说:“FDA今日批准Belviq(绿卡色林盐酸盐),作为低热量饮食和锻炼的辅助,用以长期控制体重。”

该药通过激活血清素2C受体作用于大脑中的受体控制食欲。

FDA说,试验表明,这种药物与安慰剂相比,可帮助患者在治疗一年后平均减少身体重量的3%-3.7%。

它被批准用于身体质量指数(BMI)≥30的肥胖成人,或BMI≥27的体重超重且至少患一种体重相关疾病(如高血压、2型糖尿病,或高胆固醇)的成年人。

“肥胖威胁着患者的整体健康,是一个重大的公共卫生问题,”FDA的药物评价和研究中心主任Janet Woodcock说。

上一种在美国获批的抗肥胖药物是1999年批准的由罗氏生产的赛尼可(奥利司他)。

Alli是赛尼可的非处方药形式,由葛兰素史克公司销售,它的工作原理是阻止身体吸收脂肪,但其导致胃肠道副作用(如油性稀便)的倾向遏制了它在患者中的受欢迎程度。(环球医学)

原文:

First Drug in 13 Years to Treat Obesity Approved in US

A drug called lorcaserin, marketed as Belviq and made by Arena Pharmaceuticals was approved by the US Food and Drug Administration on Wednesday as the first drug to treat obesity in 13 years. 

"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 percent 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 (BMI) 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 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.

 

相关链接:http://www.medindia.net/news/first-drug-in-13-years-to-treat-obesity-approved-in-us-103322-1.htm

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