U.S. FDA panel: Novo Nordisk's liraglutide safe, effective for obesity美国FDA专家委员会：诺和诺德的利拉鲁肽治疗肥胖症安全有效

By David Morgan

海南医学院附属医院内分泌科 王新军 译

WASHINGTON (Reuters) - Novo Nordisk's drug liraglutide is safe and effective enough to warrant approval for use in chronically obese patients with at least one weight-related health issue, an advisory panel to the U.S. Food and Drug Administration concluded on Thursday.

华盛顿(路透社2014年09月12日) 美国食品和药品管理局的顾问委员会周四认为，诺和诺德的药物利拉鲁肽用于治疗至少伴有一项肥胖相关并发症的慢性肥胖患者是安全有效的，建议FDA批准此药。

The panel voted 14 to 1 to recommend the drug, which is already approved to treat diabetes under the brand name Victoza. It would be sold under the name Saxenda if approved for obesity by the FDA. According to analysts, it could generate $1 billion in revenue for the company.

顾问委员会以14:1的投票建议批准利拉鲁肽，此前利拉鲁肽已经被批准用于治疗糖尿病，其商品名为诺和力。如果此药被FDA批准用于治疗肥胖症，其销售的商品名为Saxenda。据分析，利拉鲁肽将为诺和诺德公司产生10亿美金的收入。

The FDA typically follows the recommendations of its advisory panels. Just before the vote, Novo Nordisk shares rose 1.8 percent to $46.78 in trading on the New York Stock Exchange.

FDA通常会遵循顾问委员会的建议。就在投票前，诺和诺德的股票在纽约股票交易中增长了1.8%，达到46.78美元。

In a study, half of obese patients given a daily 3 mg injection lost at least 5 percent of body weight, while 22 percent lost more than 10 percent. The drug is proposed for use in patients who also have at least one other weight-related condition, such as hypertension.

在一项研究中，肥胖患者每天注射3mg利拉鲁肽，一半的患者能够减轻体重至少5%，而22%的患者能够减轻体重10%以上。建议利拉鲁肽用于至少合并一项肥胖相关并发症(如高血压)的患者。

The lone opposition vote came from Dr. David Kelsen of the MemorialSloanKetteringCancerCenter, who said the research did not allay concerns about the potential for increased cancer risks. "Until that information is available, there is a risk of uncertainty," he said.

唯一投反对票的是Memorial Sloan Kettering癌症中心的David Kelsen博士，他认为该研究并没有减轻对潜在的增加癌症风险的顾虑。“在获得足够的信息之前，仍然有不确定的风险”David Kelsen博士说。

An FDA report released on Tuesday noted an imbalance in the number of breast malignancies among women who took the drug but said the available data neither supports nor denies the potential role of the drug in cancer promotion or progression.

FDA在周二的报告提到在使用利拉鲁肽的女性其乳腺癌的患者数有差异，但认为目前的数据既不支持也不能否认此药在癌症发生或发展中的潜在作用。

The drug is also associated with higher resting heart rates and gallbladder-related problems.

利拉鲁肽也与较高的静息心率和胆囊疾病有关。

Some panelists found little reason to worry about elevated risks but agreed that more study would be welcome, given that patients were studied for only 52 weeks.

一些顾问专家认为没有理由过于担心风险的增加，但欢迎进行更多的研究，因为患者仅仅观察了52周。

"Overall, there is a benefit," said Dr. William Hiatt of the University of Colorado School of Medicine. “If you lose weight in this manner, patients can report an improvement in their quality of life and in their physical functioning."

“总体上看，患者是受益的”科罗拉多大学医学院William Hiatt博士说。“如果能通过此药减轻体重，患者会报告说他们的生活质量和体能有改善”。

Panel members heard from 20 public witnesses. Two cautioned against recommendation, saying long-term cardiovascular and cancer risks have not been adequately assessed, particularly for blacks and Hispanics, who are vulnerable to obesity.

顾问委员会成员也听取了20个公众人员的意见。其中2人反对此建议，认为其长期的心血管和癌症风险仍未充分评估，尤其是较易发生肥胖的黑人和西班牙人。

Others, including some tearful obesity suffers, urged the committee to favor liraglutide in hopes of delivering an effective therapy for people who are unable to control their weight through diet and exercise.

其他人，包括一些深受肥胖之苦的患者，催促委员会支持利拉鲁肽，以给予那些通过饮食和锻炼仍不能控制体重的人们一种有效的治疗方法。

More than one-third of American adults are obese, according to the U.S. Centers for Disease Control and Prevention. Excess weight is a leading cause of heart disease, stroke, diabetes and certain cancers. But safe treatments remain elusive.

根据美国疾病预防控制中心的数据，有三分之一以上的美国成年人肥胖。超重是心脏病、卒中、糖尿病和一些癌症的主要致病因素。但目前仍然缺乏安全有效的治疗方法。

If approved, Saxenda would compete with Vivus Inc's Qsymia and Belviq from Arena Pharmaceuticals Inc and Eisai. It would also compete with a new drug from Orexigen Inc that was approved on Wednesday.

如果利拉鲁肽(Saxenda)被批准，此药将和Vivus Inc公司Qsymia和Arena Pharmaceuticals Inc和Eisai公司的Belviq竞争市场，也将和周三刚刚被批准的Orexigen Inc的减肥药竞争。

(Additional reporting Toni Clarke; Editing by David Gregorio and Dan Grebler)