A blockbuster Eli Lilly drug for type 2 diabetes now has an additional FDA approval in chronic weight management, a regulatory decision that positions the pharmaceutical giant to more directly compete in cardiometabolic conditions against a Novo Nordisk molecule that has become a sales juggernaut in its own right..

一款用于2型糖尿病的重磅炸弹Eli Lilly药物现在在慢性体重管理方面获得了FDA的额外批准，这是一项监管决定，该决定使制药巨头能够更直接地在心脏代谢条件下与诺和诺德分子竞争，诺和诺德分子已成为一种销售巨头。对。。

Lilly’s new drug is the same as its type 2 medication Mounjaro, but it will be marketed under the brand name Zepbound. The Indianapolis-based drugmaker expects Zepbound will become available in the U.S. by the end of this year.

礼来公司的新药与其2型药物Mounjaro相同，但将以Zepbound品牌销售。位于印第安纳波利斯的药剂师预计到今年年底美国将有Zepbound上市。

The FDA approved Zepbound as a way to help patients lose weight and keep it off. The Wednesday regulatory decision covers obese adults with a body mass index of 30 or greater. It may also be prescribed to overweight adults who have a BMI of 27 or greater and at least one weight-related problem, such as hypertension, type 2 diabetes, cardiovascular disease, or obstructive sleep apnea.

美国食品和药物管理局（FDA）批准了Zepbound作为帮助患者减肥和保持减肥的一种方法。周三的监管决定涵盖了体重指数为30或更高的肥胖成年人。对于体重指数为27或更高且至少有一个体重相关问题的超重成年人，如高血压，2型糖尿病，心血管疾病或阻塞性睡眠呼吸暂停，也可以开处方。

The drug, administered as a once-weekly injection, is intended for use alongside diet and exercise, similar to Mounjaro’s approved use in type 2 diabetes..

该药物每周一次注射，旨在与饮食和运动一起使用，类似于Mounjaro批准用于2型糖尿病。。

The main active ingredient in both Mounjaro and Zepbound is tirzepatide, a peptide designed to bind to this GLP-1 receptor. Doing so stimulates the secretion of the blood sugar-regulating hormone insulin, an effect that was the basis for tirzepatide’s approval in type 2 diabetes last year. But activating GLP-1 also regulates appetite.

Mounjaro和Zepbound的主要活性成分是tirzepatide，一种设计用于结合该GLP-1受体的肽。这样做可以刺激血糖调节激素胰岛素的分泌，这一效应是去年tirzepatide批准2型糖尿病的基础。但激活GLP-1也会调节食欲。

The drug’s effect of helping people feel more full and eat less was the basis for its additional approval in weight management..

这种药物帮助人们感觉更饱，吃得更少的效果是其在体重管理方面获得额外批准的基础。。

Novo Nordisk’s diabetes drug Ozempic and weight loss drug Wegovy work the same way, employing a peptide called semaglutide to hit GLP-1. But unlike semaglutide, Lilly’s peptide also simultaneously binds to another receptor called GIP. Nonclinical research suggests activating GIP may further help patients manage how much they eat..

诺和诺德的糖尿病药物Ozempic和减肥药Wegovy以同样的方式工作，使用称为semaglutide的肽来击中GLP-1。但与semaglutide不同，Lilly的肽也同时与另一种称为GIP的受体结合。非临床研究表明，激活GIP可能会进一步帮助患者管理他们吃了多少。。

The FDA decision for Zepbound is based on the results of two placebo-controlled studies enrolling 2,519 total patients who were obese or overweight and had at least one weight-related condition. Those participants were randomly assigned to receive one of three doses of the study drug or a placebo. At 72 weeks, participants at all three dose levels showed statistically significant weight loss compared to the placebo arm..

FDA对Zepbound的决定是基于两项安慰剂对照研究的结果，共纳入2519名肥胖或超重且至少有一种体重相关疾病的患者。这些参与者被随机分配接受三剂研究药物或安慰剂中的一种。在72周时，与安慰剂组相比，所有三种剂量水平的参与者显示统计学显着的体重减轻。。

The larger of the two clinical trials enrolled adults without diabetes. At baseline, the average body weight was 105 kg (231 pounds) and the average BMI was 38. The FDA said participants in this study who randomly received the highest dose of Zepbound lost an average 18% of their body weight compared to those given a placebo..

两项临床试验中较大的一项纳入了无糖尿病的成年人。在基线时，平均体重为105kg（231磅），平均BMI为38。FDA表示，与安慰剂组相比，随机接受最高剂量Zepbound的这项研究的参与者平均体重减轻了18%。。

“Obesity and overweight are serious conditions that can be associated with some of the leading causes of death such as heart disease, stroke and diabetes,” John Sharretts, director of the Division of Diabetes, Lipid Disorders, and Obesity at the FDA said in a prepared statement. “In light of increasing rates of both obesity and overweight in the United States, today’s approval addresses an unmet medical need.”.

FDA糖尿病，脂质紊乱和肥胖司主任John Sharretts说：“肥胖和超重是严重的疾病，可能与心脏病，中风和糖尿病等一些主要死亡原因有关。准备声明。“鉴于美国肥胖和超重率的上升，今天的批准解决了未满足的医疗需求。”。

Side effects reported in the clinical studies include nausea, diarrhea, vomiting, constipation, and stomach discomfort and pain. The drug’s label carries a black box warning that notes the drug caused thyroid C-cell tumors in rat studies, adding that this risk in humans is unknown. The same warning is flagged on Mounjaro’s label.

临床研究报告的副作用包括恶心，腹泻，呕吐，便秘，胃部不适和疼痛。该药物的标签带有黑匣子警告，指出在大鼠研究中药物引起的甲状腺C细胞肿瘤，并补充说这种人类风险未知。Mounjaro的标签上标记了相同的警告。

One key difference between the two labels is Zepbound’s cautions that the drug may lead to suicidal thoughts and behavior. That warning is also found on Wegovy’s label..

两个标签之间的一个关键区别是Zepbound警告说，这种药物可能导致自杀的想法和行为。这个警告也可以在Wegovy的标签上找到。。

Just like Mounjaro, Lilly will supply Zepbound in six doses that can be administered by an autoinjector pen. The new drug’s $1,059.87 list price is in line with Mounjaro’s price and about 20% below the cost of Novo Nordisk’s Wegovy for weight loss.

就像Mounjaro一样，礼来公司将提供六种剂量的Zepbound，可以通过自动注射器笔进行给药。新药1059.87美元的标价与Mounjaro的价格一致，比诺和诺德的Wegovy减肥成本低约20%。

In a note sent to investors, Leerink Partners analyst David Risinger wrote that Lilly explained its pricing of Zepbound at a discount to Wegovy as a strategy to increase access to the drug. Employers primarily focus on list price as they do not have much visibility on net price, which is the list price minus any rebates or discounts.

Leerink Partners分析师David Risinger在给投资者的一份说明中写道，礼来公司解释了其对Zepbound的折扣定价，作为增加获得该药物的策略。雇主主要关注标价，因为他们对净价格没有太多的知名度，即标价减去任何折扣或折扣。

Lilly wants to drive access to Zepbound in the obesity market, and the company’s management told Leerink that “obesity is very different from a market like diabetes in which employer opt-ins are not a dynamic.”.

礼来公司希望在肥胖市场上推动进入Zepbound，公司的管理层告诉Leerink，“肥胖与像糖尿病这样的市场有很大的不同，在这个市场中，雇主的选择不是动态的”。

Mounjaro, approved last year, is already Lilly’s second-largest seller behind only the diabetes drug Trulicity. In its report of third quarter 2023 financial results last week, Lilly reported Mounjaro accounted for $1.4 billion in sales. For the year to date, the drug generated more than $2.9 billion in revenue.

去年获得批准的Mounjaro已经是礼来公司仅次于糖尿病药物真实性的第二大卖方。在上周2023年第三季度的财务成果报告中，礼来公司报告Mounjaro的销售额为14亿美元。迄今为止，该药的收入超过29亿美元。

Adding Zepbound can help Lilly catch up to Novo Nordisk..

添加Zepbound可以帮助礼来赶上诺和诺德。。

In its quarterly financial update last week, Novo Nordisk reported Ozempic accounted for 65.6 billion Danish kroner (about $9.4 billion) in sales. Wegovy generated 21.7 billion Danish krone (about $3 billion) in revenue.

在上周的季度财务更新中，诺和诺德报告Ozempic的销售额为656亿丹麦克朗（约94亿美元）。Wegovy创造了217亿丹麦克朗（约30亿美元）的收入。

Photo by Eli Lilly

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